Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00900419|
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : June 15, 2018
RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer and from normal volunteers may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer and in normal volunteers.
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Head and Neck Cancer Lung Cancer Precancerous Condition||Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: sputum cytology Procedure: biopsy|
- Determine intermediate biomarkers of premalignant respiratory epithelial lesions, such as genetic mutations or altered growth factor expression, in patients with dysplasia of the respiratory epithelium or lung cancer, head and neck cancer, or aerodigestive tract cancer.
- Establish a tissue repository of normal and dysplastic respiratory epithelium from endobronchial forceps and brush biopsy tissue from these patients and from normal volunteers.
OUTLINE: Patients are stratified according to presence of extensive and severe dysplasia of the respiratory epithelium (yes vs no).
Participants undergo sputum cytology, white-light (with or without fluorescence) bronchoscopy, and endobronchial biopsies. Participants also undergo endobronchial brushings and bronchial secretion collection and possibly bronchoalveolar lavage. Collected samples are processed by hematoxylin, eosin, and immunohistochemical staining and analyzed for specific biomarkers. Unused samples are stored in the tissue bank.
PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Biomarkers and Dysplastic Respiratory Epithelium|
|Study Start Date :||March 2002|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2018|
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: sputum cytology
- Procedure: biopsy
- Genetic mutations or altered growth factor expression [ Time Frame: After study has completed ]
- Establishment of a tissue repository of normal and dysplastic respiratory epithelium [ Time Frame: After study has closed ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900419
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Clinical Trials Office - University of Colorado Cancer Center 303-724-1650|
|Principal Investigator:||York E. Miller, MD||University of Colorado, Denver|