DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01785342
• Lead Sponsor: Boston University

Brief Summary

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.

Detailed 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 goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging \& molecular markers) that results in the most robust diagnostic predictor will be evaluated.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Status Verified: 2022-02
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung Cancer	2 years	Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.

Trial Locations

Locations (15)

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

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