CompletedNot applicableNCT00897364
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forLung Cancer · Precancerous Condition

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 15, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Colorado, Denver

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Colorado, Denver
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 15, 2020. Always confirm current availability with the study team.

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