CompletedNot Applicable

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

United States112 participantsStarted 2000-05

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. \- 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Molecular and biochemical profiles

Timeframe: Upon completion of trial

Trial details

NCT IDNCT00897364

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-12-01

View on ClinicalTrials.gov More Lung Cancer trials

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. \- 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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria