Clinical Trial VICCTHO1078
Nashville Early Diagnosis Lung Cancer Project
- Protocol No. VICCTHO1078
- Open Date: 04/12/2011
- Staging: NA
- Age Group: Adults
- Scope: Local
- Objective: To analyze the associate between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer. To identify and validate biomarkers that are associated with lung cancer risk factors and pre-malignant lesions. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).
- Disease Sites: Miscellaneous; Lung
- Therapies: None Specified
- Drugs: None Specified
- Participating Institutions: Veterans Administration; Vanderbilt University
- National Clinical Trial ID: NCT01475500
- Secondary Protocol No: VICC THO 1078
|Ages Eligible for Study:||55 Years to 74 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 10 year Bach risk model >2.5%, (55•74 years of age, Current smoker with at least 25 years of smoking, at least 10 cigarettes/day, or Former smoker at least 20 pack-per-year (PPK) history of cigarette smoking total, who quit 20 years ago or less)
• Plus one of the following:
• Forced expiratory volume in 1 second (FEV1) <70% predicted
• Or at least one first-degree relative with a diagnosis of lung cancer
• Or emphysema , moderate or severe
• Or history of resected lung cancer with no evidence of disease at 2 year follow up.
• Or history of treated head/neck and/or esophageal cancer with no evidence of disease at 1 year post intervention.
• History of diagnosis/treatment of lung cancer in the past 2 years or of head/neck or esophageal cancer in the last 1 year.
• Inability to provide informed consent
• Chest CT within the last 12 months