Lung Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Estimated Enrollment:

665

Study ID:

NCT02504697

Recruitment Status:

Active, not recruiting

Sponsor:

Boston University

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There are 14 Locations for this study

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Regents of the University of California LA (Los Angeles VA Healthcare System)
Los Angeles California, 90073, United States
University of California Los Angeles Medical Center
Los Angeles California, 90095, United States
Naval Medical Center San Diego
San Diego California, 92134, United States
Denver Research Institute
Denver Colorado, 80220, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Boston VA Research Institute, Inc
Boston Massachusetts, 02132, United States
Health Research Inc. Roswell Park Division
Buffalo New York, 14263, United States
Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Veterans Research Foundation of Pittsburgh
Pittsburgh Pennsylvania, 14520, United States
Middle Tennessee Research Institute (Vanderbilt University)
Nashville Tennessee, 37212, United States
Dallas VA Research Corporation
Dallas Texas, 75216, United States
San Antonio Military Medical Center
San Antonio Texas, 78219, United States
Naval Medical Center Portsmouth
Portsmouth Virginia, 23708, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

665

Study ID:

NCT02504697

Recruitment Status:

Active, not recruiting

Sponsor:


Boston University

How clear is this clinincal trial information?

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