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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
May 9, 2009
March 2, 2017
May 2000
May 2018   (Final data collection date for primary outcome measure)
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.
Molecular and biochemical profiles
Complete list of historical versions of study NCT00897364 on ClinicalTrials.gov Archive Site
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.
Occurrence of abnormalcies
Not Provided
Not Provided
 
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls

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.

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.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
endobronchial biopsies, blood, sputum, urine
Non-Probability Sample
High risk for lung cancer and age matched normal volunters
  • Lung Cancer
  • Precancerous Condition
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
78
May 2018
May 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00897364
95-413
P50CA058187 ( US NIH Grant/Contract Award Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: York E. Miller, MD University of Colorado, Denver
University of Colorado, Denver
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP