Active Not RecruitingNot applicableNCT04165564
Official study title

DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

Study 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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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedInstitutional standard of care and Biosamples of airway and blood

The study team can explain what participation involves.

Who it may be forPulmonary Disease

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Observational

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?Boston University

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Boston University
Interventions being studied
Other: Institutional standard of care; Other: Biosamples of airway and blood
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Reasons someone may not be able to joinExclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama, BirminghamBirmingham, Alabama
  • University of California Los AngelesLos Angeles, California
  • VA Greater LA Healthcare SystemLos Angeles, California
  • Naval Medical Center San DiegoSan Diego, California
  • University of IowaIowa City, Iowa
  • Walter Reed Army Medical CenterBethesda, Maryland
  • VA Boston Healthcare SystemBoston, Massachusetts
  • University of MichiganAnn Arbor, Michigan
  • Mayo ClinicRochester, Minnesota
  • Cleveland ClinicCleveland, Ohio
  • American College of Radiology [Administrative Site]Philadelphia, Pennsylvania
  • University of Pennsylvania School of MedicinePhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 1, 2026. Always confirm current availability with the study team.

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