Abbreviated Name

NEDLCP (Pierre Massion Project, 2015)

Lead Investigator

Grogan, Eric — Vanderbilt -Ingram Cancer Center

Coordinating Investigator

Grogan, Eric — Vanderbilt -Ingram Cancer Center

Involved Investigators

• Grogan, Eric — Vanderbilt -Ingram Cancer Center

Abstract

Objective: In this prospective cohort we will test whether repeated measure of biomarkers of risk allows early detection of lung cancer. Detailed information on the suspected risk factors, clinical test results, CT and bronchoscopy results and tissue analysis would be complimentary in the detection of early lung cancer. Research Design We will validate candidate biomarkers in a prospective high risk cohort study by designing a series of nested case control study and use time series events to approach the prediction of tumor development. The samples collected will constitute a repository that will be made available to the EDRN community. Methods We collect clinical and demographic information and research biospecimens prospectively on high risk individuals in Nashville. We will: (a) analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer, (b) identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions, (c) assess the association between patient characteristics and test results to the genetic and histological characteristics of lung cancers, d) describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention). Clinical Relevance Lung cancer is the leading cause of cancer-related death in the U.S. The 5 year survival of stage IA disease is up to 80% and stage IV disease <1%. The 5year relative survival rate for localized lung cancer is 49.5% for the same period 4. Early detection by Low dose chest CT has been shown to save lives. To identify the population at the utmost risk is a priority. The relative risk of death from lung cancer is greater in smokers, in individuals with high levels of exposure to asbestos, in individuals with completely resected stage I lung cancer or have undergone surgery for laryngeal cancer. Obstructive lung disease also appears to be a significant risk factor for the development of lung cancer 10. All these risk factors provide about 70% accuracy at predicting who will develop lung cancer. The goal is to demonstrate that molecular tools may improve this estimate significantly and provide new means of selecting high risk individuals for surveillance (screening) and chemoprevention. Subject Enrollment Inclusion criteria: 55-80 years of age, current or former smoker, if former smoker quit within 15 years, 30 PKY smoking history. We enrolled 480 participants.

Aims

We collect clinical and demographic information and research biospecimens prospectively on high risk individuals in Nashville. We will: (a) analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer, (b) identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions, (c) assess the association between patient characteristics and test results to the genetic and histological characteristics of lung cancers, d) describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).

Analytic Method

n/a per site

Comments

Study primary outcome measure is to compare candidate biomarkers over time among participants who did and did not develop lung cancer. Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly for 5 years screening results will be compared in the two groups.

Outcome

Objective: In this prospective cohort we will test whether repeated measure of biomarkers of risk allows early detection of lung cancer. Detailed information on the suspected risk factors, clinical test results, CT and bronchoscopy results and tissue analysis would be complimentary in the detection of early lung cancer. Research Design We will validate candidate biomarkers in a prospective high risk cohort study by designing a series of nested case control study and use time series events to approach the prediction of tumor development. The samples collected will constitute a repository that will be made available to the EDRN community. Methods We collect clinical and demographic information and research biospecimens prospectively on high risk individuals in Nashville. We will: (a) analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer, (b) identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions, (c) assess the association between patient characteristics and test results to the genetic and histological characteristics of lung cancers, d) describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention). Clinical Relevance Lung cancer is the leading cause of cancer-related death in the U.S. The 5 year survival of stage IA disease is up to 80% and stage IV disease <1%. The 5year relative survival rate for localized lung cancer is 49.5% for the same period 4. Early detection by Low dose chest CT has been shown to save lives. To identify the population at the utmost risk is a priority. The relative risk of death from lung cancer is greater in smokers, in individuals with high levels of exposure to asbestos, in individuals with completely resected stage I lung cancer or have undergone surgery for laryngeal cancer. Obstructive lung disease also appears to be a significant risk factor for the development of lung cancer 10. All these risk factors provide about 70% accuracy at predicting who will develop lung cancer. The goal is to demonstrate that molecular tools may improve this estimate significantly and provide new means of selecting high risk individuals for surveillance (screening) and chemoprevention. Subject Enrollment Inclusion criteria: 55-80 years of age, current or former smoker, if former smoker quit within 15 years, 30 PKY smoking history. We enrolled 480 participants.

Publications

• Establishing a Cohort and a Biorepository to Identify Biomarkers for Early Detection of Lung Cancer: The Nashville Lung Cancer Screening Trial Cohort.

Biomarkers

• Combined CYFRA 21-1 plus Clinical and Radiomic panel

Data Collections

• No data collections available at this time for this protocol.

 Team Project

Start Date

Nov 1 2010

Estimated Finish Date

Nov 1 2017

Finish Date

Oct 18 2021

Protocol ID

404

Protocol Type

Collaboration

Fields of Research

• Epigenomics
• Genomics
• Glycomics
• Hypermethylation
• Metabolomics
• Nanotechnology
• Other
• Proteomics

Collaborative Group

Lung and Upper Aerodigestive Cancers Research Group

Cancer Types

• Malignant neoplasm of bronchus and lung