DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

NCT04165564 | Active Not Recruiting

• 1 other identifier: H-39556
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 19

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.

Conditions

Pulmonary Disease

Keywords

Indeterminate pulmonary nodules; Molecular biomarkers for lung cancer diagnosis; Imaging for lung cancer diagnosis; High risk smokers

Outcome Measures

Primary Outcomes (1)

• Incidence of lung cancer

  The number of new cases of lung cancer that developed divided by the population at risk.

  3 years

Study Arms (2)

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; Other: Biosamples of airway and blood

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; Other: Biosamples of airway and blood

Interventions

Institutional standard of care OTHER

Institutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)

Group 1 - Screening; Group 2 - Incidental

Biosamples of airway and blood OTHER

Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

Group 1 - Screening; Group 2 - Incidental

Eligibility Criteria

• Age: 46 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston University: lead
• Johnson & Johnson: collaborator
• American College of Radiology Imaging Network: collaborator

Study Sites (19)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

VA Greater LA Healthcare System

Los Angeles, California, 90095, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Walter Reed Army Medical Center

Bethesda, Maryland, 20889, United States

Location

VA Boston Healthcare System

Boston, Massachusetts, 02110, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

American College of Radiology [Administrative Site]

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Brown University [Administrative Site]

Providence, Rhode Island, 02912, United States

Location

VA Tennessee Valley Healthcare System

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center [Administrative Site]

Houston, Texas, 77030, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Nasal brushing, Buccal scraping, Stool, Bronchial Biopsy, Bronchial brushing, Lung tissue

MeSH Terms

Conditions

Lung Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: August 24, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (19)