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Clinical Trials/NCT03181256
NCT03181256
Active, not recruiting
Not Applicable

Early Detection of Lung Cancer in the Medically Underserved Population

Vanderbilt-Ingram Cancer Center1 site in 1 country45 target enrollmentDecember 14, 2017
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Vanderbilt-Ingram Cancer Center
Enrollment
45
Locations
1
Primary Endpoint
Candidate biomarkers of risk or of early diagnosis
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

Detailed Description

PRIMARY OBJECTIVES: I. To provide screening for lung cancer in an underserved and high risk population for lung cancer. II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals. III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer. IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions. V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers. VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention). OUTLINE: Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.

Registry
clinicaltrials.gov
Start Date
December 14, 2017
End Date
December 1, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Grogan

Associate Professor of Thoracic Surgery

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

Inclusion Criteria

  • Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years
  • \>= 30 pack year of smoking history
  • Participant is uninsured

Exclusion Criteria

  • History of diagnosis/treatment of lung cancer in the past 2 years
  • History of head/neck or esophageal cancer in the last 1 year
  • Inability to provide informed consent

Outcomes

Primary Outcomes

Candidate biomarkers of risk or of early diagnosis

Time Frame: Up to 5 years.

Will validate the performance of the candidate biomarkers of risk or of early diagnosis.

Study Sites (1)

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