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| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2007 | ||||
| Last Updated Date | June 9, 2009 | ||||
| Start Date ICMJE | June 1995 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00559325 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | DNA Analysis in Predicting Lung Cancer Risk | ||||
| Official Title ICMJE | DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer | ||||
| Brief Summary | RATIONALE: Studying samples of blood, urine, and tissue from patients with lung cancer and from other 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 predict risk for developing lung cancer. PURPOSE: This clinical trial is studying the DNA in blood, urine, and tissue samples from patients with lung cancer and from other participants. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Cases and controls undergo a structured, in-person interview assessing prior medical history and cancer history, tobacco use, alcohol use, current medications, occupational history, family medical history, menstrual history and estrogen use, recent nutritional supplement use, caffeine intake, and socioeconomic status. Cases and controls also undergo blood and urine sample collection for DNA analysis. The phenotypic markers studied will assess DNA repair with cellular response by using lymphocyte cultures exposed in vitro to radiation, bleomycin, and benzo(a)pyrene-diol-epoxide and measuring induction of chromosomal aberrations, p53 induction, and apoptosis. DNA from cases and controls are also used for genetic polymorphism analysis of carcinogen metabolism, and those related to the dopaminergic system and nicotinic receptors. Previously collected tumor tissue samples from cases are evaluated for estrogen and progesterone receptors. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | April 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 | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00559325 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000566029, NCI-OH98-C-N027 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
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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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