Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Precancerous Condition |
Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls |
- Molecular and biochemical profiles [ Time Frame: Upon completion of trial ] [ Designated as safety issue: No ]
- Occurrence of abnormalities [ Time Frame: Upon completion of trial ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
endobronchial biopsies, blood, sputum, urine
| Estimated Enrollment: | 78 |
| Study Start Date: | May 2000 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
High risk for lung cancer/normal volunters
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
Contacts and Locations| United States, Colorado | |
| University of Colorado Cancer Center at UC Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: | York E. Miller, MD | University of Colorado, Denver |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00897364 History of Changes |
| Other Study ID Numbers: | 95-0413, P50CA058187 |
| Study First Received: | May 9, 2009 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
non-small cell lung cancer small cell lung cancer squamous lung dysplasia |
Additional relevant MeSH terms:
|
Lung Neoplasms Precancerous Conditions Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013