Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00897364
First received: May 9, 2009
Last updated: May 5, 2014
Last verified: May 2014

May 9, 2009
May 5, 2014
May 2000
May 2015   (final data collection date for primary outcome measure)
Molecular and biochemical profiles [ Time Frame: Upon completion of trial ] [ Designated as safety issue: No ]
Molecular and biochemical profiles [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897364 on ClinicalTrials.gov Archive Site
Occurrence of abnormalities [ Time Frame: Upon completion of trial ] [ Designated as safety issue: No ]
Occurrence of abnormalcies [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

endobronchial biopsies, blood, sputum, urine

Non-Probability Sample

High risk for lung cancer/normal volunters

  • Lung Cancer
  • Precancerous Condition
Other: laboratory biomarker analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
78
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897364
95-0413, P50CA058187
No
University of Colorado, Denver
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: York E. Miller, MD University of Colorado, Denver
University of Colorado, Denver
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP