IRB Study Number 20-874
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
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.
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)
