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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897364
First received: May 9, 2009
Last updated: January 27, 2010
Last verified: June 2007
History of Changes
  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
Official Title: Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Molecular and biochemical profiles [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of abnormalcies [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: May 2000
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 abnormalcies 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
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
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 Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center     720-848-0650        
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Investigators
Principal Investigator: York E. Miller, MD University of Colorado, Denver
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00897364     History of Changes
Other Study ID Numbers: CDR0000378079, UCHSC-95-413
Study First Received: May 9, 2009
Last Updated: January 27, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 May 22, 2013