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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: N/A
  • 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

None Provided.

Eligibility

Ages Eligible for Study:55 Years to 74 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• 50•79 years of age, Current smoker with at least 25 years of smoking, at least 10 cigarettes/day, or former smoker at least 20 PKY history of cigarette smoking total, who quit 20 years ago or less
• 6 year risk of ≥2.5% using Tammemagi Lung Cancer Risk Prediction Calculator:
• 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