DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

NCT ID: NCT01785342

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 489 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2022-02-28

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Indeterminate Pulmonary Nodule

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. Biosample and imaging collection will be done.

Biosample and Imaging Collection

Intervention Type: OTHER

Collection of listed biosamples and CT imaging.

Interventions

Biosample and Imaging Collection

Collection of listed biosamples and CT imaging.

Intervention Type: OTHER

Other Intervention Names

Blood,; Urine,; Buccal Scraping,; Nasal,; Bronchial Brushing,; Bronchial Biopsy,; Lung Tissue,; Sputum,; CT Imaging of Chest

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American College of Radiology Imaging Network

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ehab Billatos, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Deni Aberle, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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

Countries

United States

References

Kinsey CM, Billatos E, Mori V, Tonelli B, Cole BF, Duan F, Marques H, de la Bruere I, Onieva J, San Jose Estepar R, Cleveland A, Idelkope D, Stevenson C, Bates JHT, Aberle D, Spira A, Washko G, San Jose Estepar R. A simple assessment of lung nodule location for reduction in unnecessary invasive procedures. J Thorac Dis. 2021 Jul;13(7):4207-4216. doi: 10.21037/jtd-20-3093.

Reference Type: DERIVED

PMID: 34422349 (View on PubMed)

Billatos E, Ash SY, Duan F, Xu K, Romanoff J, Marques H, Moses E, Han MK, Regan EA, Bowler RP, Mason SE, Doyle TJ, San Jose Estepar R, Rosas IO, Ross JC, Xiao X, Liu H, Liu G, Sukumar G, Wilkerson M, Dalgard C, Stevenson C, Whitney D, Aberle D, Spira A, San Jose Estepar R, Lenburg ME, Washko GR; DECAMP and COPDGene Investigators. Distinguishing Smoking-Related Lung Disease Phenotypes Via Imaging and Molecular Features. Chest. 2021 Feb;159(2):549-563. doi: 10.1016/j.chest.2020.08.2115. Epub 2020 Sep 16.

Reference Type: DERIVED

PMID: 32946850 (View on PubMed)

Billatos E, Duan F, Moses E, Marques H, Mahon I, Dymond L, Apgar C, Aberle D, Washko G, Spira A; DECAMP investigators. Detection of early lung cancer among military personnel (DECAMP) consortium: study protocols. BMC Pulm Med. 2019 Mar 7;19(1):59. doi: 10.1186/s12890-019-0825-7.

Reference Type: DERIVED

PMID: 30845938 (View on PubMed)

Other Identifiers

U01CA196408

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-31755

Identifier Type: -

Identifier Source: org_study_id