R01CA264995

Optimizing Lung Cancer Screening in Cancer Survivors - The goal of the proposal is to identify optimal lung cancer (LC) screening strategies for breast (BC), prostate (PC), and colorectal (CRC) cancer survivors.

We will accomplish these goals by developing and validating a novel multi-racial and ethnic lung cancer model (MELCAM) that will simulate LC development, progression, screening, treatment, and survival in a multiethnic cancer survivor population. We will then assess the effectiveness and cost-effectiveness (CE) of different LC screening strategies for these survivors.

All together, there are over 6 million BC, CRC, and PC survivors in the US. As these cancers tend to be diagnosed in early stages, many survivors live for a long time and may develop and die from second cancers. Cancer survivors are also at an increased risk of developing LC due to relatively high rates of smoking (up to 50-60%), age, and treatment-related side effects. As a result, over 15% of LC cases are diagnosed in cancer survivors, making LC the top cause of cancer-related mortality in this population.

Little is known about optimal LC screening for cancer survivors who have been excluded from prior randomized trials (RCT) and have a different harm/benefit ratio from screening due to the competing risk of death from their first cancer and higher burden of comorbidities. The lack of data to guide decisions about LC screening in cancer survivors has a profound negative impact on survivorship, including under and overuse of LC screening, resulting in worse outcomes and increased healthcare costs.

It is unlikely that RCTs assessing the benefits of LC screening for cancer survivors will ever be conducted. Thus, there is an urgent need to use alternative methods to determine the optimal screening strategy for these patients. In this study, we propose using simulation modeling, an approach complementary to RCTs, to assess the harms and benefits of LC screening in cancer survivors.

The specific aims are to:

(1) Derive and validate a model (MELCAM), based on a well-established framework, to simulate LC screening in BC, PC, and CRC cancer survivors from diverse racial and ethnic backgrounds.

(2) Determine the most effective and CE strategies for LC screening in BC survivors.

(3) Identify the optimal LC screening strategies in PC survivors and determine their CE.

(4) Evaluate the effectiveness and CE of LC screening for CRC survivors.

To achieve these aims, we will use data from several large, representative, population-based cancer cohorts and robust harmonization methods to develop, calibrate, and validate MELCAM by incorporating the development, screening, work-up, treatment, and survival of LC in multiethnic survivors of BC, PC, and CRC (Aim 1). We will then use the model to simulate RCTs evaluating the effectiveness (in terms of maximizing survival, quality of life, and other patient-centered outcomes) and CE of LC screening regimens (eligibility, frequency, and duration) in these cancer survivors (Aims 2-4).

The study will be innovative in applying state-of-the-art modeling approaches to evaluate LC screening in a diverse population of cancer survivors, and the results will have direct implications for the management of a large group of survivors.

Icahn School Of Medicine At Mount Sinai

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

New York, New York 100296504 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 375% from $718,813 to $3,415,788.