Lung CancerNCT00897364
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
An observational study of Lung Cancer and Precancerous Condition, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Precancerous Condition
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to 1 Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: High risk for lung cancer and age matched normal volunters
Who may be able to join
- - 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.
Who cannot join
- - Clinically apparent bleeding diathesis.
- - 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.
- - 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- non-small cell lung cancer, small cell lung cancer, squamous lung dysplasia
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon completion of trial
Secondary outcomes (1)
Occurrence of abnormalities
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.
Measured: Upon completion of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2000
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- York E. Miller, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897364
- Sponsor's protocol ID
- 95-413
- Other IDs
- P50CA058187
- Status last verified
- May 2020
- First submitted
- 9 May 2009
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls
- ClinicalTrials.gov ID
- NCT00897364
- Acronym / sponsor ID
- 95-413
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- non-small cell lung cancer, small cell lung cancer, squamous lung dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2000
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- High risk for lung cancer and age matched normal volunters
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (7 listed)
- - Clinically apparent bleeding diathesis.
- - 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.
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Occurrence of abnormalities
Time frame: Upon completion of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
York E. Miller, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Precancerous Condition, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular and biochemical profiles (time frame: Upon completion of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.