DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

Pulmonary Disease Clinical Trial

Official title:

DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04165564
• Other study ID #: H-39556
• Status: Active, not recruiting
• Start date: August 24, 2020
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 46 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Disease

Intervention

Other:
• Institutional standard of care
Institutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)
• Biosamples of airway and blood
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Walter Reed Army Medical Center	Bethesda	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	VA Boston Healthcare System	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	MD Anderson Cancer Center [Administrative Site]	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of California Los Angeles	Los Angeles	California
United States	VA Greater LA Healthcare System	Los Angeles	California
United States	West Virginia University	Morgantown	West Virginia
United States	VA Tennessee Valley Healthcare System	Nashville	Tennessee
United States	American College of Radiology [Administrative Site]	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Brown University [Administrative Site]	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	American College of Radiology Imaging Network, Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lung cancer	The number of new cases of lung cancer that developed divided by the population at risk.	3 years