- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475500
Nashville Early Diagnosis Lung Cancer Project
This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies.
The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis.
The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: Sputum sample
- Procedure: Pulmonary function tests
- Radiation: Computerized tomography (CT) scan of the chest
- Other: Buccal epithelium collection
- Procedure: Nasal brushings
- Procedure: Bronchoscopy
- Procedure: Bronchoalveolar lavage
- Procedure: Blood sample collection
- Procedure: Urine sample
- Procedure: Questionnaire-data collection
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37212
- Veterans Administration
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Nashville, Tennessee, United States, 37232
- Vanderbilt University, Vanderbilt-Ingram Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 55 - 80 years of age
- Current smoker or former smoker. If former smoker, must have quit smoking less than 15 years ago
- >/= 30 pack year of smoking history
Exclusion Criteria:
- History of diagnosis/treatment of lung cancer in the past 2 years
- History of head/neck or esophageal cancer in the last 1 year
- Inability to provide informed consent
- Participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (DVT, mechanical heart valves, unstable coronary syndrome, etc.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Screening
These high-risk subjects will undergo screening for lung cancer.
All subjects will undergo all listed interventions
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This is a collection of sputum (mucous) you cough up.
Three morning samples will be collected at one time.
Sputum will be collected at baseline, year 1, year 2 and year 5.
A series of different breathing tests designed to measure lung function and to determine the presence or absence of chronic obstructive pulmonary disease will be performed at baseline.
A CT scan uses x-rays to take detailed pictures of the chest.
Performed at baseline, year 2 and year 5.
If nodules are present, CT scans will be performed every 3 months for the first year of the study.
Collect cells from the inside of the cheek.
Samples will be collected at baseline and yearly to year 5.
A cytobrush is used to remove cells on the surface of the inside of the nose.
Samples will be collected at baseline and yearly to year 5.
A flexible tube with a light and a camera will be inserted through the nose or mouth, and into the lungs to look at the airway.
Bronchial tissue will be obtained.
During a bronchoscopy, a flexible tube with a light and a camera is passed through the mouth or nose into the lungs and fluid is squirted into a small part of the lung and collected for examination.
Bronchoscopies will be performed at baseline and at year 5.
A venous blood sample will be collected for testing of biomarkers and other relevant tests.
Blood will be taken at baseline and yearly to year 5.
Urine will be collected for routine urine tests at baseline and yearly to year 5.
A questionnaire about the patient's health, medical, and smoking history.
Administered at baseline and yearly to year 5. Data will be taken from patient interviews and from the medical record.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare candidate biomarkers over time among participants who did and did not develop lung cancer
Time Frame: at baseline and yearly to year 5
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Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer.
Baseline and yearly screening results will be compared in the two groups.
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at baseline and yearly to year 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions.
Time Frame: at baseline and yearly to year 5
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Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for presently unknown biomarkers that occur in patients with lung cancer and in patients who do not have lung cancer but who may be at further increased risk of lung cancer.
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at baseline and yearly to year 5
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To assess changes in prevalence and grade of pre-invasive lesions in this cohort.
Time Frame: baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months)
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Endobronchial tissue will be examined under a microscope for presence of changes in the cells that are abnormal but which are not invasive cancer.
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baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months)
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To describe patients eligible for future chemoprevention clinical trials.
Time Frame: at year 5
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Inclusion criteria for those patients who, based on their biomarker profile, are at increased risk of invasive lung cancer and who may benefit from clinical trials that will study chemoprevention strategies for lung cancer.
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at year 5
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Grogan, MD, Vanderbilt-Ingram Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC THO 1078
- U01CA152662 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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