Clinical trial NCT04165564: DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
Official title: DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Disease
Keywords: Indeterminate pulmonary nodules
Molecular biomarkers for lung cancer diagnosis
Imaging for lung cancer diagnosis
High risk smokers
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: American College of Radiology Imaging Network
First posted: 2019-11-18
Enrollment: 85
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility 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)

Primary outcomes:
measure: Incidence of lung cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: VA Greater LA Healthcare System
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Bethesda
country: United States
facility: Walter Reed Army Medical Center
state: Maryland
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: American College of Radiology [Administrative Site]
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Brown University [Administrative Site]
state: Rhode Island
city: Nashville
country: United States
facility: VA Tennessee Valley Healthcare System
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center [Administrative Site]
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Boston University
name: Ehab Billatos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Denise Aberle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: George Washko, MD
role: PRINCIPAL_INVESTIGATOR
References: