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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: May 9, 2009
Last updated: January 13, 2016
Last verified: January 2016

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

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Molecular and biochemical profiles [ Time Frame: Upon completion of trial ]

Secondary Outcome Measures:
  • Occurrence of abnormalities [ Time Frame: Upon completion of trial ]

Biospecimen Retention:   Samples With DNA
endobronchial biopsies, blood, sputum, urine

Estimated Enrollment: 78
Study Start Date: May 2000
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
High risk for lung cancer/normal volunters


  • 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


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00897364

United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: York E. Miller, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT00897364     History of Changes
Other Study ID Numbers: 95-413  P50CA058187 
Study First Received: May 9, 2009
Last Updated: January 13, 2016

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
Lung Diseases
Respiratory Tract Diseases processed this record on February 17, 2017