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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00897364
Collaborator
National Cancer Institute (NCI) (NIH)
112
Enrollment
1
Location
115
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    112 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls
    Study Start Date :
    May 1, 2000
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. Molecular and biochemical profiles [Upon completion of trial]

      Evaluation of both Molecular and Biochemical profiles of normal non-smokers, smokers with no apparent disease (no airflow obstruction or cancer), and smokers with airflow obstruction and abnormal sputum cytology.

    Secondary Outcome Measures

    1. Occurrence of abnormalities [Upon completion of trial]

      Stratify abnormalities as to whether they occur frequently in normal non-smokers, smokers without disease, smokers with various grades of dysplasia, or smokers with lung cancer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      • Adults > 45 years of age, to be age matched with a previously enrolled cohort of current and ex-smokers with airflow obstruction and moderate atypia on sputum cytology, to be included in the following groups.
      • Non-smoking (less than 100 cigarettes per lifetime) controls >50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction (FEV1 < 75% predicted and FEV1/FVC < 75%) and moderate atypia on sputum cytology.
      • Current smokers with > 30 pack years, no airflow obstruction (FEV1 > 90% predicted) or lung cancer, >50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction and moderate atypia on sputum cytology .
      • No prior history of a head and neck or bronchogenic carcinoma.
      • Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and FDA guidelines.
    Exclusion Criteria:
      • Clinically apparent bleeding diathesis.
      • Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2/minute) premature ventricular contractions are not exclusionary.
      • Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.
      • Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.
      • Acute bronchitis or pneumonia within 8 weeks.
      • Inability to give informed consent.
      • Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    • Principal Investigator: York E. Miller, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT00897364
    Other Study ID Numbers:
    • 95-413
    • P50CA058187
    First Posted:
    May 12, 2009
    Last Update Posted:
    May 15, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    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

    Study Results

    No Results Posted as of May 15, 2020