Lung Cancer Clinical Trial

DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

Summary

DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and non-invasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.

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Full Description

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that previously initiated the DECAMP-1 and DECAMP-2 studies for lung cancer early detection. Now, with the support of Johnson and Johnson, 3 Veterans Administration Hospitals (VAH), 3 Military Treatment Facilities (MTF) and 12 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores, we are expanding our work in lung cancer early detection.

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Eligibility Criteria

Inclusion Criteria:

Radiologic diagnosis of solid indeterminate pulmonary nodule (0.8 to 2.5 cm) identified in the past 3 months OR semi-solid (mixed density) nodule with solid component of at least 0.6 cm identified in the past 12 months; must be of appropriate size at enrollment.
CT scan completed within 3 months prior to enrollment
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 approximately three years from enrollment
Able to complete the Patient Lung History questionnaire with study staff

Arm 1 - Screening

Age 55-77 years old
Current and former smokers with 30 pack-years or more(and quit less than 15 years ago)

Arm 2 - Incidental

Age > 45 years old
Current and former smokers with 10 pack-years or more(and quit less than 15 years ago)

Exclusion Criteria:

History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (not including non-melanoma skin cancer)
Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis)
Diagnosis of pure ground glass opacities for the target lesion on chest CT within the last 12 months (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable as mentioned above)

Study is for people with:

Lung Cancer

Estimated Enrollment:

85

Study ID:

NCT04165564

Recruitment Status:

Active, not recruiting

Sponsor:

Boston University

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There are 18 Locations for this study

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University of Alabama, Birmingham
Birmingham Alabama, 35233, United States
University of California Los Angeles
Los Angeles California, 90095, United States
VA Greater LA Healthcare System
Los Angeles California, 90095, United States
Naval Medical Center San Diego
San Diego California, 92134, United States
University of Iowa
Iowa City Iowa, 52242, United States
Walter Reed Army Medical Center
Bethesda Maryland, 20889, United States
VA Boston Healthcare System
Boston Massachusetts, 02110, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
American College of Radiology [Administrative Site]
Philadelphia Pennsylvania, 19103, United States
University of Pennsylvania School of Medicine
Philadelphia Pennsylvania, 19104, United States
Temple University
Philadelphia Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Brown University [Administrative Site]
Providence Rhode Island, 02912, United States
VA Tennessee Valley Healthcare System
Nashville Tennessee, 37232, United States
MD Anderson Cancer Center [Administrative Site]
Houston Texas, 77030, United States
Naval Medical Center Portsmouth
Portsmouth Virginia, 23708, United States
West Virginia University
Morgantown West Virginia, 26505, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

85

Study ID:

NCT04165564

Recruitment Status:

Active, not recruiting

Sponsor:


Boston University

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