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

Lung Cancer Clinical Trial

Official title:

Molecular Predictors of Lung Cancer Behavior: Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899457
• Other study ID #: VICC THO 0734
• Secondary ID: P50CA090949P30CA
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: June 23, 2014
• Start date: April 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Vanderbilt University Human Research Protection Program
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Healthy participant

• No history of smoking

• No history of cancer

PATIENT CHARACTERISTICS:

• SWOG performance status 0

• No clinically apparent bleeding diathesis

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease
• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• proteomic profiling
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

Other:
• biologic sample preservation procedure
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath
• laboratory biomarker analysis
Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath

Procedure:
• bronchoscopy
Collection of breath condensate.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of biological specimens to use as controls in the study of lung cancer progression	Specimens are collected from healthy participants with no known risk of lung cancer	Off study date, up to one year	No
Secondary	Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung		off-study date, up to one year	No
Secondary	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	No