Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
| Tracking Information | |||||
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| First Received Date ICMJE | May 9, 2009 | ||||
| Last Updated Date | August 10, 2012 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Collection of biological specimens to use as controls in the study of lung cancer progression [ Time Frame: Off study date, up to one year ] [ Designated as safety issue: No ] Specimens are collected from healthy participants with no known risk of lung cancer |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00899457 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants | ||||
| Official Title ICMJE | Molecular Predictors of Lung Cancer Behavior: Controls | ||||
| Brief Summary | RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer. PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Healthy, non-smokers. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Healthy, non-smokers
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 37 | ||||
| Estimated Completion Date | August 2012 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00899457 | ||||
| Other Study ID Numbers ICMJE | VICC-THO-0734, P50CA090949, P30CA068485, VU-VICC-THO-0734, VICC-THO-0734 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center | ||||
| Study Sponsor ICMJE | Vanderbilt-Ingram Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt-Ingram Cancer Center | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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