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Active, Not Recruiting

NCT Number: NCT02504697

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regents of the University of California LA (Los Angeles VA Healthcare System), Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biosamples from airway and blood

Other

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

Primary outcomes

  1. Lung Cancer

    Time frame: Four years

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • American College of Radiology Imaging Network

Registry information

Official study 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

Acronym: DECAMP-2

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2015
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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