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
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

High risk for lung cancer/normal volunters

Criteria

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
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 ClinicalTrials.gov identifier: NCT00897364

Locations
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
Investigators
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: May 5, 2014
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 September 18, 2014