Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 46 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Group 1 - Screening Participants in this group will be 55-77 years old and currently smoke or were former smokers with 30 pack-years or more (and quit less than 15 years ago)
  • 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)
  • Other: Biosamples of airway and blood
    Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
Group 2 - Incidental Participants in this group will be > 45 years old and currently smoke or were former smokers with 10 pack-years or more (and quit less than 15 years ago)
  • 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)
  • Other: Biosamples of airway and blood
    Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

More Details

Status
Active, not recruiting
Sponsor
Boston University

Study Contact

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.