|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | DNA Analysis in Predicting Lung Cancer Risk | ||||
| Official Title † | 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. |
||||
| 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. |
||||
| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | |||||
| Primary Outcome Measure † | Prediction of lung cancer risk based on mutagen sensitivity, p53 induction, and apoptosis in cultured lymphocytes Development of phenotypic or predictive markers of lung cancer, including mutagen sensitivity, DNA damage-induced cell cycle checkpoints, and serum proteomics |
||||
| Secondary Outcome Measure † | Gene-neuro-behavioral interactions for smoking addiction in the control groups Relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk |
||||
| Condition † | Lung Cancer | ||||
| Intervention † | Procedure: evaluation of cancer risk factors Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: polymorphism analysis Procedure: proteomic profiling Procedure: questionnaire administration |
||||
| MEDLINE PMIDs | 17848669, 16896050, 16230422, 12584177, 17301252 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 3000 | ||||
| Start Date † | June 1995 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00559325 | ||||
| Organization ID | CDR0000566029 | ||||
| Secondary IDs †† | NCI-OH98-C-N027 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | November 15, 2007 | ||||
| Last Updated Date | October 18, 2008 | ||||