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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.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00897364
First received: May 9, 2009
Last updated: March 2, 2017
Last verified: March 2017
  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
Lung Cancer
Precancerous Condition

Study Type: Observational
Study Design: Observational Model: Other
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 ]
    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:
  • Occurrence of abnormalities [ Time Frame: 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.


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

Estimated Enrollment: 78
Study Start Date: May 2000
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
High risk for lung cancer and age matched normal volunters
Criteria

Inclusion Criteria:

  1. - 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.
  2. - 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.
  3. - 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 .
  4. - No prior history of a head and neck or bronchogenic carcinoma.
  5. - 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:

  1. - Clinically apparent bleeding diathesis.
  2. - 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.
  3. - Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.
  4. - 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.
  5. - Acute bronchitis or pneumonia within 8 weeks.
  6. - Inability to give informed consent.
  7. - Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.
  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
National Cancer Institute (NCI)
Investigators
Principal Investigator: York E. Miller, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00897364     History of Changes
Other Study ID Numbers: 95-413
P50CA058187 ( US NIH Grant/Contract Award Number )
Study First Received: May 9, 2009
Last Updated: March 2, 2017

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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 24, 2017