DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Study Overview
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Brief Summary
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The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

Detailed Description
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The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that includes 7 Veterans Administration Hospitals (VAH), the 4 designated Military Treatment Facilities (MTF) and 4 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores. The DECAMP Coordinating Center will facilitate rapid selection, design and execution of clinical studies within this multi-institutional consortium. The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging & molecular markers) that results in the most robust diagnostic predictor will be evaluated.

Official Title
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Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Biosample and Imaging Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45 years of age or older; Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm); Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked) Willing to undergo fiberoptic bronchoscopy; 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 a minimum of two years; Able to fill out Patient Lung History questionnaire; Willing and able to provide a written informed consent. Exclusion Criteria: History or previous diagnosis of lung cancer; Diagnosis of pure ground glass opacities on chest CT; Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness; Allergies to any local anesthetic that may be used to obtain biosamples in the study.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indeterminate Pulmonary Nodule<br>The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. Biosample and imaging collection will be done. | Other: Biosample and Imaging Collection<br>* Collection of listed biosamples and CT imaging.<br>* Other names: CT Imaging of Chest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Cancer | Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period. | 2 years |