Early detection

Biomarker or biomarker testing

Liquid biopsy

Risk profile

Squamous cell lung cancer

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Early detection and prognosis of lung cancer using bioengineered implants

2023

Pierre Massion Young Investigator Award for Early Detection Research

Ramon Ocadiz Ruiz, PhD

University of Michigan

Ann Arbor

Dr. Ocadiz Ruiz proposes to develop a bioengineered scaffolding and test it in mouse models. If successful, this research could progress to a phase 1 clinical trial and lay the groundwork for a new technology to be used in individuals with increased risk of lung cancer. This technology has to potential to make biopsies and consequently, early detection, easier.

Research Summary

Lung cancer is the leading cause of cancer related deaths, resulting in 1.8 million deaths annually. The current lung cancer detection and monitoring modality is primarily focused on imaging, which unfortunately identifies disease only after it has reached a detectable size that represents significant burden of disease. Therefore, new affordable and efficient lung cancer diagnostic and monitoring approaches are needed. We propose the use of a subcutaneous implant that acts as a surrogate for the lung, which can capture tumor and immune cells at early stages of the disease, providing critical information about cancer cells and their environment. This device collects cells within the device, which can be biopsied without significant risk to the patient. With this technology we will detect and monitor cancer cells prior to overt symptoms and avoiding invasive lung biopsies that have significant associated risks. The information collected with this technology will help the clinician identify disease while the burden is low, and the analysis of the tumor cells can be used to select targeted therapies to improve patient outcomes.

Technical Abstract

Lung cancer is the leading cause of cancer related death among women and men and the second most diagnosed cancer in the world, causing 1.8 million deaths annually. Surgical resection of the primary tumor is the standard of care whenever possible. However, 90% of lung cancer deaths are caused by metastases months-to-years after surgery. Current screening tools such as high-resolution Computed Tomography (CT) and Positron Emission Tomography (PET) can only identify tumors that have reached a detectable size, that often correlates with advanced disease. However, this technology carries side problems, including the false positive rate that led to follow-up tests and invasive procedures that confers additional risks to patients.

Therapeutic strategies targeting specific driver mutations have emerged in recent years for the treatment of metastatic non-small cell lung cancer and have improved survival, yet the initial identification of these molecular alterations depends on biopsies of metastatic lesions after the resection of the primary tumor. For biopsy, the metastatic lesion must be large enough to be detectable by clinical imaging tools, and this large lesion indicates a relatively advanced stage of disease. Biopsy of these lesions is often difficult from both location and patient-safety perspective. An emerging option is a blood draw or liquid biopsy to obtain circulation tumor DNA (ctDNA) for mutation analyses, yet the ctDNA is not abundant in circulation until relatively large metastases have already formed.

Therefore, novel, efficient, and affordable approaches are needed for disease surveillance. We propose a high sensitive, minimally-invasive and efficient cell capture device for easy isolation of tumor cells at early stages of disease, whose analysis can identify targeted therapeutics that can be applied while the disease burden and heterogeneity are low. Furthermore, this technology would increase the coverage of the eligible population and reduce the clinical costs by using histopathology analysis of the sentinel implant. This device is a porous biomaterial scaffold that, when implanted, is vascularized, and infiltrated by immune cells and subsequently cancer cells, acting as a synthetic sentinel niche that provides information about the disease development and progression. Our previous studies in breast and pancreatic cancer models have demonstrated that tumor cells are detectable early after tumor initiation and during the progression of the disease. A comparative analysis of scaffolds and ctDNA showed that the implant captured and therefore detected cancer cells before positive detection of ctDNA.

We will determine the genomic and transcriptomic prolife of inoculated lung cancer cells in PDX’s murine model at early time points. We anticipate that the tumor cells captured by the scaffolds will recapitulate the genotype of the parental PDX. The scaffold safety will be investigated in a Phase I clinical study of metastatic lung cancer patients implanted with our scaffold, with biopsy and subsequent removal to analyze captured cells. Sequencing analysis will be applied to captured cancer cells to assess their genomic and transcriptomic profile. We foresee the use of these bioengineered implants for surveillance in high-risk lung cancer patients, with analysis of the collected cells employed to identify personalized therapeutic strategies to improve patient outcome.

Key words

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Comparative Effectiveness of Lung Cancer Screening Strategies

2023

Pierre Massion Young Investigator Award for Early Detection Research

Lawrence Benjamin, MD

University of California Los Angeles

Los Angeles

Dr. Benjamin’s research focuses on improving the rates of lung cancer screening. Currently, there is interest in “centralizing” lung cancer screening into self-contained programs or one-stop shops, with dedicated support staff and clinical personnel to coordinate shared decision-making, scheduling imaging, and arranging appropriate follow-up care. However, it is poorly understood how these centralized programs compare to “decentralized” screening that is coordinated by primary care physicians directly with their patients. Dr. Benjamin seeks to utilize nationwide longitudinal data from multiple lung cancer screening programs from the Veterans Affairs Healthcare System to evaluate and compare the performance of centralized versus decentralized screening programs, with particular focus on highlighting their effectiveness within various racial and income groups.

Research Summary

Lung cancer is the leading cause of cancer-related death. Those at high risk for developing lung cancer from smoking are recommended to undergo screening for lung cancer yearly. However, despite this recommendation for nearly a decade, few who are eligible get screened, and even fewer follow up after their first screening. Lung cancer screening programs should investigate the effectiveness of their organizational structure and how well it serves their patients. The proposed study seeks to study the impact of a lung cancer screening programs organizational structure on its performance amongst various demographic groups using data from the Veterans Affairs Healthcare System.

Technical Abstract

Lung cancer is the leading cause of cancer-related mortality. Lung Cancer Screening (LCS) with an annual low-dose computed tomography (LDCT) scan has been recommended by the United States Preventive Services Task Force (USPSTF) since 2013, but uptake and adherence has been quite poor, estimating less than 20% of those eligible get screened. Additionally, there is a lack of consensus or high quality data to compare implementation strategies for lung cancer screening programs, and how these perform at reaching patients from different demographic backgrounds. Recently, there has been increasing interest in “centralizing” lung cancer screening into self-contained programs, with dedicated support staff and clinical personnel to coordinate shared decision making, scheduling of imaging, and arranging appropriate follow up. It is poorly understood how these centralized programs may compare at scale to “decentralized” screening that is coordinated by Primary Care Physicians directly with their outpatients. The proposed study seeks to utilize nationwide longitudinal data from multiple lung cancer screening programs from the Veterans Affairs Healthcare System to evaluate the comparative performance of centralized versus decentralized screening programs, and specifically highlighting their performance amongst various racial and income groups.

Key words

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Integration of Liquid Biopsy Assays for the Early Detection of Lung Cancer

2023

Early Detection Research Award

Maximilian Diehn, MD, PhD

Stanford University

Stanford

Lung cancer is the number one cause of cancer-related deaths in the US because it is often found only after it has spread to other organs in the body, decreasing the likelihood of surviving at least 5 years after diagnosis. Only 21% of patients are diagnosed then their lung cancer is early stage, when it is most treatable. The goal of this project is to create a new way to screen for lung cancer using a blood sample that can find early stage disease when patients can still be treated and/or cured. In preliminary work, Dr. Diehn has developed a blood test that can identify tiny amounts of DNA from lung cancer cells and in this study he will improve this test and apply it to patients and healthy controls. If successful, Dr. Diehn’s work has the potential to significantly improve early detection of lung cancer and improve outcomes for patients.

Research Summary

Lung cancer is the number one cause of cancer-related deaths in the U.S. and can affect both smokers and non-smokers. Lung cancer is often deadly because it is usually found after it has spread to other organs like the brain, liver, or bones, at which point it is no longer possible to cure the disease in most patients. But if caught early when the cancer cells are still confined to the lung, it can often be cured with surgery or radiation. Screening for lung cancer in current or former smokers using CT scans has been proven to reduce the number of patients who die from lung cancer by catching the disease early. Although insurance covers it in the U.S., only about 15% of those who qualify actually get screened. Some reasons for this low rate of screening include worries about false positives from CT scans and difficulty accessing radiology facilities. Our goal is to create a new way to screen for lung cancer using a blood sample that can find early stage cancers when they can still be cured. Our method looks for tiny amounts of DNA in the blood that comes from lung cancer cells. We have completed initial tests that show our idea could work. Now, we plan to further improve our test and to apply it to several hundred lung cancer patients and healthy controls. If our experiments are successful, our blood test could eventually be used alongside CT scans to cut down on unnecessary follow-up tests or even replace CT scans as the main way to screen for lung cancer. If so, this work could contribute to saving lives of patients with lung cancer.

Technical Abstract

Lung cancer is the leading cause of cancer in the U.S., with over 238,000 new cases and more than 125,000 deaths expected in 2023. Early detection is crucial for improving prognosis, and low-dose computed tomography (LDCT) scans are recommended for high-risk populations. However, LDCT screening has limitations, including a significant false positive rate and low compliance. New approaches are therefore needed to enhance early detection in high-risk individuals. Liquid biopsy assays that can detect circulating tumor DNA (ctDNA) represent a promising alternative early detection approach. Our group has developed three state-of-the-art liquid biopsy techniques that each have the potential to detect lung cancer noninvasively, including a somatic mutation approach (Lung-CLiP), a methylation-based approach (meCAPP-Seq), and a fragmentomic-based approach (EPIC-Seq). We hypothesize that combining mutation-, methylation-, and fragmentomic-based ctDNA analysis will maximize sensitivity for detecting early stage lung cancers. Our proposal includes three specific aims. In the first aim, we will compare the clinical sensitivity and specificity of meCAPP- Seq, EPIC-Seq, and Lung-CLiP for early lung cancer detection. In the second aim, we will determine the analytical limits of detection for the three methods, which is important for future regulatory considerations. In the third aim, we will develop an integrated liquid biopsy assay that combines meCAPP-Seq, EPIC-Seq, and/or Lung-CLiP. We will test if combining two or all three assays can improve performance over the best- performing single assay. The deliverable of this project will be the identification of the combination of liquid biopsy assays that achieves the best performance for early lung cancer detection. If successful, our work has the potential to significantly improve early lung cancer detection which would lead to improved outcomes for lung cancer patients.

Key words

Biomarker or biomarker testing

Liquid biopsy

Risk profile

Squamous cell lung cancer

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VA-CEDAR Tool for Equity in Lung Cancer Screening

2023

Veterans Affairs Research Scholar Award

Neelima Navuluri, MD, MPH

Durham VA Medical Center

Durham

The veteran population is disproportionately affected by lung cancer and relatively few patients that are eligible participate in lung cancer screening. This low participation is due to barriers such as provider bias, structural racism, patient mistrust, and fear of diagnosis. In this project, Dr. Navuluri proposes to develop and test an electronic shared decision-making aid and referral tool to improve equity in lung cancer screening (LCS). She will pilot test the aid to assess its feasibility and usability among patients and providers within the Durham VA system.

Research Summary

Lung cancer is the most common cause of cancer death in the United States and Veterans are disproportionately affected. Lung cancer screening (LCS) provides an important opportunity to better diagnose and treat lung cancer, thus reducing the number of deaths among high risk patients. However, relatively few patients participate in LCS programs such as the one offered by the Durham Veterans Affairs Healthcare System and participation rates among communities of color are especially low. This low LCS participation is in part to due to barriers related to shared decision making, or the process in which providers and the patient share knowledge about the individualized risks and benefits of LCS. These barriers may include fear of cancer diagnosis, patient mistrust, structural racism, and provider biases. The goal of our study is to develop an intervention centered on shared decision making that improves equity in LCS decision making and participation. We will obtain and incorporate direct input from a diverse group of Veterans, providers, and community advisory board members to develop and refine and electronic shared decision aid and referral tool to aid Veterans and providers in engaging in shared-decision making regarding LCS. The tool will also facilitate streamlined low- dose CT orders for eligible and interested Veterans. We will also test this tool among real patients and providers at the Durham VA.

Technical Abstract

Lung cancer is the most common cause of cancer mortality in the United States and Veterans are disproportionately affected. Lung cancer screening (LCS) using annual low-dose computed tomography (CT) scans substantially reduces lung cancer mortality by nearly one-quarter. Yet, uptake of LCS within the Durham Veterans Affairs Healthcare System is low as compared to other cancer screening programs, with participation rates among Black Veterans, Veterans from rural areas, and Veterans with mental health comorbidities being especially low. Barriers and facilitators to LCS include fear of cancer diagnosis, patient mistrust, structural racism, and provider biases, all of which impact shared-decision making around LCS. This study aims to develop an intervention using human centered design and community-based participatory research methodologies which can potentially improve equity in LCS shared decision making, referral, and participation and then pilot test the intervention to assess its feasibility, acceptability and usability. We hypothesize that the intervention will take the form of an electronic-shared decision aid and referral tool which will facilitate streamlined CT orders for eligible and interested Veterans and that it will be feasible, acceptable, and usable among both Veterans and VA providers.

Key words

Veterans Affairs

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The Germline-Somatic Interaction in Young-Onset Lung Cancer

2023

Career Development Award

This grant was funded in part by Lung Cancer Initiative

Jaclyn LoPiccolo, MD, PhD

Dana-Farber Cancer Institute

Boston

Although the average age at diagnosis is 70, thousands of new patients under 45 are diagnosed with lung cancer every year, most of whom have never smoked. Dr. LoPiccolo hypothesizes that these patients may share inherited genetic changes that predispose them to developing lung cancer at a younger age. In a preliminary analysis of young-onset lung cancer patients, Dr. LoPiccolo has found that approximately 30% of these patients carry rare mutations in known cancer-associated genes. In this study, Dr. LoPiccolo will investigate whether these mutations affect response to targeted or immune-based therapies. This insight is likely to identify risk factors among young lung cancer patients, which could lead to improved screening and treatment options for this population.

Research Summary

Lung cancer is the most common cause of cancer death in both men and women. Although the average age at lung cancer diagnosis is 70, thousands of new lung cancers occur in patients under 45 years old, most of whom have never smoked. There have been few efforts to analyze potential causes of young-onset lung cancer, particularly looking for inherited genetic changes, which are present in all cells in the body, that are shared among these patients and might predispose to developing lung cancer at a young age. To investigate whether inherited genes cause lung cancer in young patients, we collected blood samples from more than 350 lung cancer patients aged 45 and under at diagnosis and sequenced their genomes. In a preliminary analysis of 243 patients, we found that roughly 30% of young lung cancer patients carry rare, harmful inherited mutations in known cancer-associated genes, higher than many cancers known to have a strong genetic component. In addition to predicting cancer risk, inherited mutations that are present in every cell may influence how a tumor behaves and responds to treatment. We hypothesize that understanding the inherited contribution to tumor development may affect the response of cancer to targeted or immune-based therapies. Additionally, finding genetic risk factors could identify a group of people eligible for yearly CT screening and early detection of lung cancer (currently only used only for patients over 50 years old with heavy smoking histories), and/or guide therapies for lung cancer patients in the future.

Technical Abstract

Lung cancer is the most common cause of cancer-related mortality in North America. Although the average age at diagnosis is 70, thousands of new lung cancers are diagnosed each year in patients under 45 years over 45 years old (median age of diagnosis = 67). The work proposed here will further define this difference in a larger cohort, and address whether the identified variants or genes affect tumor evolution and treatment outcomes. The aims of our study are to identify a population of young lung cancer patients with elevated germline risk, and to investigate the mechanism of the germline-somatic interaction in young lung cancer. The young lung cancer population also provides a lens through which to better understand oncogene-driven lung cancer that occurs in non-smokers – increasingly important as global smoking rates decline.old, most of whom have never smoked. Given that younger patients develop lung cancer decades earlier and without known environmental insults, we hypothesized that underlying germline genetic variation predisposes to developing lung cancer at a young age. Here, we assembled a cohort of over 350 patients diagnosed with lung cancer at age 45 or younger and performed germline whole-genome sequencing (WGS). Preliminary data from 243 patients with median diagnosis age of 37 showed at least 30% of patients carry clinically actionable pathogenic germline alterations in cancer-associated genes, at rates exceeding those seen in many other cancer types – with key age-specific differences when compared to ancestry-matched lung cancer patients from The Cancer Genome Atlas diagnosed over 45 years old (median age of diagnosis = 67). The work proposed here will further define this difference in a larger cohort, and address whether the identified variants or genes affect tumor evolution and treatment outcomes. The aims of our study are to identify a population of young lung cancer patients with elevated germline risk, and to investigate the mechanism of the germline-somatic interaction in young lung cancer. The young lung cancer population also provides a lens through which to better understand oncogene-driven lung cancer that occurs in non-smokers – increasingly important as global smoking rates decline.

Key words

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Promoting lung cancer screening in Latinx patients with previous HNSCC

2022

Health Equity and Inclusiveness Junior Investigator Award

Coral Olazagasti, MD

University of Miami

Miami

In addition to tobacco use, having a previous malignancy is a risk factor for developing lung cancer. Head and neck cancer (HNC) survivors with a history of smoking have up to a 13% risk of developing lung cancer. Dr. Olazagasti’s study will assess the awareness and eligibility of lung cancer screening in Hispanic/LatinX HNC survivors via a survey questionnaire and understand the barriers to screening via qualitative interviews. The goal of her research is to create the first lung cancer screening program tailored for and focused exclusively on Hispanic/LatinX HNC survivors.

Research Summary

Hispanics/LatinX comprise the largest-growing minority group in the U.S. They account for 18.5% of the total U.S. population1 and are projected to increase to 26%, surpassing Non-Hispanic Whites (NHW) and becoming the largest group in the U.S. by 2045. Despite large national representation in the U.S., data demonstrates that this population faces barriers to healthcare access. These barriers are often due, but not limited to socioeconomic status, lack of health insurance, limited medical literacy, language barriers, structural racism, and perceived discrimination. Studies show that Hispanics/LatinX have the highest uninsured rates compared to any other ethnic/racial group, thus limiting their ability to receive equitable health care. This lack of equitable care often leads to Hispanics/LatinX forgoing or delaying medical care, avoiding screening, placing them at elevated risk of an advanced stage of cancer diagnosis. Unlike NHW, cancer remains the most common cause of death in the Hispanic/LatinX population.

Lung cancer (LC) is the leading cause of cancer-related death for Hispanic/LatinX men and the second most common cause of death for Hispanic/LatinX women. LC carries a 5-year overall survival rate of less than 20%, mainly due to advance stage at diagnosis8. Survival rates are even lower for Hispanics/LatinX (13% vs 17%), who are more likely to be diagnosed at advanced stages of LC than their NHW counterparts (59% vs 52%). To increase the rates of early detection, different organizations have supported the use of Low Dose CT (LDCT) as a screening modality in eligible individuals, after results from the National Lung Screening Trial (NLST) showed a 20% mortality reduction in LC with the use of LDCT for screening. Unfortunately, 95% of the subjects in this trial were White and only 1.8% were Hispanic/LatinX, which is not an accurate representation of the U.S. population. Studies have shown that LatinX individuals are less aware of LC screening than NHW, but when informed are more interested in pursuing screening compared with non-LatinX.

In addition to tobacco use, having a previous malignancy is a risk factor for LC. Head and neck cancer (HNC) survivors are at increased risk of second primary lung cancer compared to the general population, largely due to their heavy smoking history. Patients with tobacco related HNC have up to a 13% risk of developing second primary LC. Currently, the guidelines recommend performing a 3-month post treatment for subjects with head and neck malignancies treated with curative intent. However, the National Comprehensive Cancer Network (NCCN) does not advise performing imaging surveillance beyond 6 months in this patient population, unless there are signs and/or symptoms to suggest cancer recurrence. In terms of LC screening, the NCCN recommends annual screening with LDCT for HNC survivors with a smoking history of 20 pack-years or more. However, no randomized control studies have been done to prospectively assess the risk of second primary LC in this high-risk population. One study created a secondary analysis of the NLST to evaluate the incidence of second primary LC in HNC survivors screened with LDCT versus chest x-ray (CXR). The study found a higher lung cancer incidence in HNC survivors compared to the rest of the study population.

The study proposed here will fill an important gap and assess the awareness and eligibility of lung cancer
screening in Hispanic/LatinX HNC survivors via a survey questionnaire and understand the barriers to
screening via qualitative interviews. We will create the first lung cancer screening program tailored for and focused exclusively on Hispanic/LatinX HNC survivors.

Technical Abstract

Hispanics/LatinX comprise the largest-growing minority group in the United States (U.S.). They account for 18.5% of the total U.S. population1 and are projected to become the largest group in the U.S. by 2045, surpassing NHW. Despite large national representation in the U.S., data demonstrates that this population faces barriers to healthcare access. These barriers are often due, but not limited to socioeconomic status, lack of health insurance, limited medical literacy, language barriers, structural racism, and perceived discrimination. Studies show that Hispanics/LatinX have the highest uninsured rates compared to any other ethnic/racial group, thus limiting their ability to receive equitable health care. This lack of equitable care often leads to Hispanics/LatinX forgoing or delaying medical care, avoiding screening, placing them at elevated risk of an advanced stage of cancer diagnosis. Unlike NHW, cancer remains the most common cause of death in the Hispanic/LatinX population.

LC is the leading cause of cancer-related death for Hispanic/LatinX men and the second most common cause of death for Hispanic/LatinX women. LC carries a 5-year overall survival rate of less than 20%, mainly due to advance stage at diagnosis. Survival rates are even lower for Hispanics/LatinX (13% vs 17%), who are more likely to be diagnosed at advanced stages of LC than their NHW counterparts (59% vs 52%). To increase the rates of early detection, different organizations have supported the use of LDCT as a screening modality in eligible individuals, after results from the NLST showed a 20% mortality reduction in LC with the use of LDCT for screening. Currently, The U.S. Preventive Services Task Force (USPSTF) recommends annual screening for LC in adults 50–80 years of age with at least a 20-pack year smoking history who are current smokers or have quit within the last 15 years. This criterion was extrapolated from the high-risk features in subjects that participated in the NLST that ultimately led to the LC screening recommendations. Unfortunately, the population in the NLST is not an accurate representation of the U.S population, as 95% of the participants were white and only 1.8% were Hispanics. Additionally, studies have shown that LatinX individuals are less aware of LC screening than NHW, but when informed, they are more LatinX interested in pursuing screening (90.7%) compared with non-LatinX (67%).

Besides tobacco use, having a previous malignancy is a risk factor for LC. HNC survivors are at increased
risk of second primary lung cancer compared to the general population, largely due to their heavy smoking history. Patients with tobacco related HNC have up to a 13% risk of developing second primary LC. Currently, the guidelines recommend performing a 3-month post treatment for subjects with head and neck malignancies treated with curative intent. However, NCCN does not advise performing imaging surveillance beyond 6 months in this patient population, unless there are signs and/or symptoms to suggest cancer recurrence. In reference to LC screening, The NCCN recommends annual screening with LDCT for HNC survivors with a smoking history of 20 pack years or more. However, no prospective studies have been performed to assess the risk of second primary LC in this high-risk population. Of the few studies that have been completed, one study completed a post hoc secondary analysis of the NLST to evaluate the incidence of second primary lung cancer in HNC survivors screened with low dose CT (LDCT) versus chest x-ray (CXR). Out of X participants, 171 HNC survivors had undergone screening. Of these, 90.1% identified as White, 4.1% as Black, and 0% as Hispanic or LatinX and lung cancer was identified in 20 (12%) of the HNC survivors screened. A total of 15% (12/82) and 9% (8/89) of the HNC survivors screened with LDCT and CXR, respectively, were diagnosed with LC. The study found a higher LC incidence in HNC survivors compared to participants without head and neck cancer, with an adjusted rate ratio of 2.54 (95% CI, 1.63-3.95). Additionally, the study found an average smoking history of 80 pack years amongst HNC survivors compared to 48 pack years in the rest of the study population.

Key words

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Investigating incidental pulmonary nodules in underserved communities

2021

Health Equity and Inclusiveness Junior Investigator Award

Neel Chudgar, MD

Montefiore Medical Center

Bronx

Research Summary

Lung cancer remains the most common cause of cancer death in the United States. Underrepresented minorities are at greater risk; Black patients have higher rates of advanced disease and worse survival for all stages. Lung cancer screening has been recommended since 2013, but remains underutilized, especially in minority communities. Care for many at-risk patients is often administered in the emergency department setting, where follow-up is fractured and incomplete. This may be particularly true for incidentally discovered lung nodules, commonly found on imaging done for other purposes, and often diagnosed later as cancers. However, when detected incidentally they are at risk of being lost to follow up with the potential to progress to more advanced stages with a greater risk of mortality. To address this need, we propose to develop an incidental pulmonary nodule management program targeted towards the underserved community cared for by our institution. Through the incorporation of software to automatically detect notation of lung nodules in radiology reports, patients with lung nodules will be captured and integrated into a nodule follow-up clinic. Individual risk for malignancy will be evaluated using artificial intelligence-based calculators derived from the electronic medical record to facilitate guideline concordant care. Finally we will evaluate a blood-based cancer biomarker to further risk stratify patients and will prospectively apply it to patients enrolled in our nodule clinic. Our overall objective is to facilitate the earlier diagnosis of lung cancer in our underserved population, in order to decrease lung cancer mortality.

Technical Abstract

A common source of lung cancer morbidity is presented by incidental pulmonary nodules (IPNs), which can represent missed cancers when incompletely followed. Underrepresented patients are particularly at risk of guidelines discordant care. Our institution cares for a large proportion of these minority communities. We therefore propose to develop a comprehensive program for the identification, risk stratification and management of IPNs identified through imaging in the emergency setting. We first seek to incorporate lung nodule detection and management software into our electronic medical record (EMR). To facilitate recognition of nodules, we will utilize natural language processing to screen and flag imaging. A multidisciplinary ensemble of practitioners will validate findings and participate in management. At the crux of this team will be a patient navigator to communicate with patients and assist in follow-up. We next seek to create an IPN risk prediction algorithm. Clinical and radiographic elements from the EMR will be subjected to artificial intelligence-based review to automatically leverage data towards a machine learning-derived algorithm. The final element of our proposal will investigate a blood-based gene expression assay as a marker for malignancy. Following its evaluation using a cohort of biobanked samples, we will apply this RNA-based detection assay to look for markers of malignancy to facilitate the early detection of lung cancers. We ultimately seek to improve lung cancer care within our largely underserved population through a combination of incorporating patients with IPNs into the health care system and providing appropriate and automated risk stratification to expedite care and diagnosis.

Key words

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Improving lung cancer screening adherence among underserved populations

2021

Health Equity and Inclusiveness Research Fellow Award

Eduardo Nunez, MD

Boston University School of Medicine

Boston

Technical Abstract

Lung cancer remains the leading cause of cancer death worldwide and clinical trials show that annual lung cancer screening with low-dose Computed Tomography can reduce lung cancer-related mortality by 20%. Marginalized populations are disproportionately affected by lung cancer and our prior work has shown that these disparities extend to lung cancer screening; in a national cohort of Veterans we found that Black Veterans, those with mental health disorders and lower income were less likely to adhere to lung cancer screening follow-up recommendations. Currently, little is known about how to optimize lung cancer screening in underserved populations and marginalized populations from diverse backgrounds.

This proposed project focuses on identifying barriers and facilitators to lung cancer screening at the patient, provider, facility and community-levels. We plan to use mixed methods to quantitatively explore factors associated with delayed or lack of adherence to lung cancer screening and then perform in-depth qualitative analysis to identify which factors are critical and modifiable. We will use an implementation strategy mapping tool to select evidence-based strategies best suited to address the identified barriers and develop a tailored implementation plan to improve adherence to lung cancer screening, both overall and among underserved populations, at Baystate Health System. This work is critical in achieving equity in lung cancer screening and improving overall lung cancer mortality among patients.

Key words

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Measuring provider engagement in lung cancer screening

2021

Veterans Affairs Research Scholar Award

Jennifer Lewis, MD, MS, MPH

Vanderbilt University Medical Center/VA-Tennessee Valley Healthcare System

Nashville

Research Summary

Fewer than 10% of eligible Veterans are screened for lung cancer with low-dose computed tomography (LDCT), and a lack of clinician engagement is one important reason for low screening rates. In this proposal, we will modify a survey tool that measures aspects of clinician engagement in lung cancer screening to better understand how to improve clinician engagement. We will perform experiments to evaluate if this measure is capturing the key concepts in engagement. We will evaluate if a provider who scores higher in certain engagement features orders more screening examinations. The results of this proposal will be used to develop an intervention to increase clinician engagement in lung cancer screening and evaluate if engagement changes before and after that intervention. Increasing clinician engagement can lead to improved screening rates and lung cancer outcomes.

Technical Abstract

Background: Provider engagement is key for successful implementation of evidence-based practices. Our prior work reported that providers’ guideline knowledge is strongly correlated to screening practices but other behavioral factors have not yet been measured in lung cancer screening.

Long-term Career Goal: To be a leader in implementation science with expertise in translating evidence-based lung cancer prevention and early detection into clinical practice through mixed-methods research (qualitative and quantitative) and pragmatic trials in the Veterans Affairs (VA). This award will advance the following career goals: To gain experience in: a) measurement science; b) quantitative analysis methods, and to transition to research independence.

Specific Aim: To measure and validate providers’ behavioral factors that influence lung cancer screening implementation.

Methodology: We will adapt the Determinants of Implementation Behavior Questionnaire (DIBQ) for lung cancer screening and leverage ongoing research infrastructure to survey primary care providers at 10 VA medical centers (VAMCs) participating in the Veterans Affairs Partnership to increase Access to Lung Screening (VA-PALS). The adapted questionnaire will be validated using factor analysis and association with prior screening practices. We will assess which behavioral factors are associated with screening using multivariable regression.

Future Directions: The data gathered will be used to design future interventions aimed at increasing provider engagement and measure how provider engagement changes before and after interventions. This proposal will advance the field of implementation science while also leading towards my independence as an implementation researcher.

Key words