DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Completed

Conditions studied: Lung Cancer

In brief

The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

Key facts

Study ID

NCT01785342

Run by

Boston University

People needed

489

Starts

2013-01-01

Expected to finish

2022-02-28

Last updated by the study team

2022-03-15

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 45 years of age or older;
• Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
• Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
• 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 minimum of two years;
• Able to fill out Patient Lung History questionnaire;
• Willing and able to provide a written informed consent.

You may not qualify if…

• History or previous diagnosis of lung cancer;
• Diagnosis of pure ground glass opacities on chest CT;
• Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
• Allergies to any local anesthetic that may be used to obtain biosamples in the study.

Where it is running

• 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
• Naval Medical Center San Diego — San Diego, California, United States
• Denver Research Institute — Denver, Colorado, 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
• 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
• Middle Tennessee Research Institute (Vanderbilt University) — Nashville, Tennessee, United States
• Dallas VA Research Corporation — Dallas, Texas, United States
• San Antonio Military Medical Center — San Antonio, Texas, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States

Full record on ClinicalTrials.gov

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