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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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Michigan
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Ann ArborUnited StatesUnknown status
Walter Reed Army Medical Center
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BethesdaUnited StatesUnknown status
University of Alabama Birmingham
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BirminghamUnited StatesUnknown status
VA Boston Healthcare System
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BostonUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
MD Anderson Cancer Center [Administrative Site]
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HoustonUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
University of California, Los Angeles
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Los AngelesUnited StatesUnknown status
VA Greater LA Healthcare System
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Los AngelesUnited StatesUnknown status
West Virginia University
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MorgantownUnited StatesUnknown status
VA Tennessee Valley Healthcare System
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NashvilleUnited StatesUnknown status
American College of Radiology [Administrative Site]
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PhiladelphiaUnited StatesUnknown status
Temple University
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PhiladelphiaUnited StatesUnknown status
University of Pennsylvania School of Medicine
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
Naval Medical Center - Portsmouth
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PortsmouthUnited StatesUnknown status
Brown University [Administrative Site]
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ProvidenceUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Naval Medical Center -San Diego
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San DiegoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.