DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer

Pulmonary Disease Clinical Trial

— DECAMP-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02504697
• Other study ID #: H-32479
• Status: Active, not recruiting
• Start date: September 2011
• Est. completion date: December 2027

Study information

• Verified date: April 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that includes 7 Veterans Administration Hospitals (VAH), the 4 designated Military Treatment Facilities (MTF) and 4 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores. The DECAMP Coordinating Center will facilitate rapid selection, design and execution of clinical studies within this multi-institutional consortium. The ACRIN 4704 study will recruit one cohort to achieve the aims of this study: a longitudinal screening cohort.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 665
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria for longitudinal screening cohort

• 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. Exclusion Criteria
• Diagnosis of lung cancer prior to the current assessment (that is, patients are eligible if first lung cancer diagnosis has been recently confirmed by bronchoscopic biopsy and is leading to resection surgery, but not if this is not a first diagnosis);
• Contraindications to nasal brushing or fiberoptic bronchoscopy, including: ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease (i.e., disease severity does not allow for bronchoscopic procedures), unstable cardiac or pulmonary disease, as well as other comorbidities leading to inability to protect airway, or altered level of consciousness;
• Allergies to any local anesthetic that may be used to obtain biosamples in the study;
• Weight greater than that allowable by the CT scanner.

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Disease

Intervention

Other:
• Biosamples from airway and blood
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Boston University Medical Center	Boston	Massachusetts
United States	Boston VA Research Institute, Inc	Boston	Massachusetts
United States	Health Research Inc. Roswell Park Division	Buffalo	New York
United States	Dallas VA Research Corporation	Dallas	Texas
United States	Denver Research Institute	Denver	Colorado
United States	Regents of the University of California LA (Los Angeles VA Healthcare System)	Los Angeles	California
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	Middle Tennessee Research Institute (Vanderbilt University)	Nashville	Tennessee
United States	Trustees of University of Pennsylvania (Philadelphia VA Medical Center)	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Veterans Research Foundation of Pittsburgh	Pittsburgh	Pennsylvania
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	American College of Radiology Imaging Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Cancer		Four years