NCT04165564Active, not recruiting
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 85 (actual)
- First submitted
- 14 Nov 2019
- Start date
- 24 Aug 2020
- Primary completion date
- Dec 2026
- Lead sponsor
- Boston University
- Diseases
- Lung cancer
- NCT number
- NCT04165564
What you commit to
- Study type: Observational
- Participants enrolled: 85
- From 24 Aug 2020 to the primary completion date, Dec 2026
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis)
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 46 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Walter Reed Army Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| VA Boston Healthcare System Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| MD Anderson Cancer Center [Administrative Site] Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| VA Greater LA Healthcare System Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| VA Tennessee Valley Healthcare System Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| American College of Radiology [Administrative Site] Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pennsylvania School of Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Naval Medical Center - Portsmouth Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| Brown University [Administrative Site] Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Naval Medical Center -San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.