This trial is active, not recruiting.

Conditions lung cancer, precancerous condition
Treatment laboratory biomarker analysis
Phase phase 2
Sponsor University of Colorado, Denver
Collaborator National Cancer Institute (NCI)
Start date May 2000
End date June 2016
Trial size 78 participants
Trial identifier NCT00897364, 95-413, P50CA058187


RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Molecular and biochemical profiles
time frame: Upon completion of trial

Secondary Outcomes

Occurrence of abnormalities
time frame: Upon completion of trial

Eligibility Criteria

Male or female participants of any age.

DISEASE CHARACTERISTICS: - Meets 1 of the following criteria: - Smoker with no disease - Smoker with airflow obstruction and abnormal sputum cytology - Smoker with lung cancer - Smoker with various grades of dysplasia - Non-smoker PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - Not specified

Additional Information

Official title Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls
Principal investigator York E. Miller, MD
Description OBJECTIVES: Primary - Define the molecular and biochemical profiles of airway epithelium of smokers with no disease, smokers with airflow obstruction and abnormal sputum cytology, and non-smokers. Secondary - Assess the occurrence of abnormalities in non-smokers, smokers with no disease, smokers with various grades of dysplasia, and smokers with lung cancer. OUTLINE: Patients are stratified according to smoking status (smoker vs non-smoker) and disease (no disease vs airflow obstruction and abnormal sputum cytology vs various grades of dysplasia vs lung cancer). Biological samples are collected and analyzed for future research studies. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.