DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Lung Cancer Clinical Trial

— DECAMP-1  

Official title:

Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785342
• Other study ID #: H-31755
• Secondary ID: U01CA196408
• Status: Completed
• Start date: January 2013
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2022
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Multiple Pulmonary Nodules

Intervention

Other:
• Biosample and Imaging Collection
Collection of listed biosamples and CT imaging.

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 (3)

Lead Sponsor	Collaborator
Boston University	American College of Radiology Imaging Network, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Cancer	Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.	2 years