Vanderbilt-Ingram Cancer Center

Clinical Trial VICCTHO1078

Title

Nashville Early Diagnosis Lung Cancer Project

Principal Investigator(s)

Pierre Massion

Details

• 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

Description

Eligibility

Criteria
 Inclusion Criteria:

 • 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.

 Exclusion Criteria:

 • 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 

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