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

NCT00897364 | Completed

• 2 other identifiers: 95-413P50CA058187
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Precancerous Condition

Keywords

non-small cell lung cancer; small cell lung cancer; squamous lung dysplasia

Outcome Measures

Primary Outcomes (1)

• Molecular and biochemical profiles

  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.

  Upon completion of trial

Secondary Outcomes (1)

• Occurrence of abnormalities

  Upon completion of trial

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High risk for lung cancer and age matched normal volunters

You may qualify if:

• \- 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.

You may not qualify if:

• \- Clinically apparent bleeding diathesis.
• \- 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

endobronchial biopsies, blood, sputum, urine

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• York E. Miller, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2000
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

US (1)