Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants

Completed

• Conditions: Healthy, no Evidence of Disease; Lung Cancer
• Interventions: Genetic: proteomic profiling; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Procedure: bronchoscopy

• Registration Number: NCT00899457
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.

PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.

Detailed Description

OBJECTIVES:

* To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.

* To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.

OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-04
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy, non-smokers	proteomic profiling	-
Healthy, non-smokers	biologic sample preservation procedure	-
Healthy, non-smokers	laboratory biomarker analysis	-
Healthy, non-smokers	bronchoscopy	-

Primary Outcome Measures

Name	Time	Method
Collection of biological specimens to use as controls in the study of lung cancer progression	Off study date, up to one year	Specimens are collected from healthy participants with no known risk of lung cancer

Secondary Outcome Measures

Name	Time	Method
Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers	off-study date, up to one year
Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung	off-study date, up to one year

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States