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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01785342
Other study ID # H-31755
Secondary ID U01CA196408
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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