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DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165564
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
Johnson & Johnson
American College of Radiology Imaging Network
Information provided by (Responsible Party):
Boston University

Brief 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.

Condition or disease Intervention/treatment
Pulmonary Disease Other: Institutional standard of care Other: Biosamples of airway and blood

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Incidence of lung cancer [ Time Frame: 3 years ]
    The number of new cases of lung cancer that developed divided by the population at risk.


Biospecimen Retention:   Samples With DNA
Blood, Nasal brushing, Buccal scraping, Stool, Bronchial Biopsy, Bronchial brushing, Lung tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   46 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are identified for inclusion in the study based on the observation of a lung nodule on screening or incidentally found by routine chest CT scans, between 0.8-2.5 cm diameter or observation of a mixed density nodule in which the solid portion is 0.6-2.5 cm diameter. These patients are managed according to institutional standard of care. This may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165564


Contacts
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Contact: Ehab Billatos, MD 617-358-7039 ebillato@bu.edu

Locations
Show Show 21 study locations
Sponsors and Collaborators
Boston University
Johnson & Johnson
American College of Radiology Imaging Network
Investigators
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Principal Investigator: Ehab Billatos, MD Boston University
Principal Investigator: Denise Aberle, MD University of California, Los Angeles
Principal Investigator: George Washko, MD Brigham and Women's Hospital
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04165564    
Other Study ID Numbers: H-39556
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Indeterminate pulmonary nodules
Molecular biomarkers for lung cancer diagnosis
Imaging for lung cancer diagnosis
High risk smokers
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases