Detection of Early Lung Cancer Among Military Personnel Study 2 (DECAMP-2): Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer

Status: Active_not_recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 79
Healthy Volunteers: t
View:

• Ages 50 to 79 years;

• Smoking status: Current or former smoker (≥10 cigarettes/day for current smokers, or ≥20 pack years for former smoker who quit 20 years ago or less)

• History of Chronic Obstructive Pulmonary Disease (COPD), emphysema, or at least one first-degree relative with a diagnosis of lung cancer;

• Willing to undergo fiberoptic bronchoscopy;

• Able to tolerate all biospecimen collection as required by protocol;

• Able to comply with standard-of-care follow-up visits, including clinical exams, diagnostic work-ups, and imaging for a maximum of four years or until diagnosis of lung cancer;

• Able to fill out Patient Lung History questionnaire;

• Willing and able to provide a written informed consent.

Locations
United States
California
Regents of the University of California LA (Los Angeles VA Healthcare System)
Los Angeles
University of California Los Angeles Medical Center
Los Angeles
Naval Medical Center San Diego
San Diego
Colorado
Denver Research Institute
Denver
Massachusetts
Boston University Medical Center
Boston
Boston VA Research Institute, Inc
Boston
Maryland
Walter Reed National Military Medical Center
Bethesda
New York
Health Research Inc. Roswell Park Division
Buffalo
Pennsylvania
Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
Philadelphia
University of Pennsylvania
Philadelphia
Veterans Research Foundation of Pittsburgh
Pittsburgh
Tennessee
Middle Tennessee Research Institute (Vanderbilt University)
Nashville
Texas
Dallas VA Research Corporation
Dallas
San Antonio Military Medical Center
San Antonio
Virginia
Naval Medical Center Portsmouth
Portsmouth
Time Frame
Start Date: 2011-09
Completion Date: 2027-12
Participants
Target number of participants: 665
Treatments
Longitudinal Cohort
For this longitudinal screening cohort, we will enroll 800 participants who currently or historically smoked and who have a 10 year Bach risk model of lung cancer \> 2.5% (5). We will include participants 50 to 79 years old, with ≥10 cigarettes/day for current smokers, or ≥20 pack years for former smoker who quit 20 years ago or less. In order to further enrich for lung cancer risk, participants also will have COPD/emphysema or at least one first-degree relative with a diagnosis of lung cancer. We will exclude patients previously diagnosed with lung cancer. These patients will be followed for a total of 4 years with annual follow-up visits. Biosamples from airway and blood and images will be collected.
Related Therapeutic Areas
Sponsors
Leads: Boston University
Collaborators: American College of Radiology Imaging Network

This content was sourced from clinicaltrials.gov