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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00897364
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : August 31, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

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
Lung Cancer Precancerous Condition

Detailed Description:



  • 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.


  • 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 Type : Observational
Estimated Enrollment : 78 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 2000
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897364

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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00897364     History of Changes
Other Study ID Numbers: 95-413
P50CA058187 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 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
Lung Diseases
Respiratory Tract Diseases