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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02504697
Other study ID # H-32479
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2011
Est. completion date December 2027

Study information

Verified date April 2024
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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