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NCT00339859 · ClinicalTrials.gov registry record
DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 5,625
- Enrollment target
NCT00339859: Completed study, sponsored by National Cancer Institute (NCI).
NCT00339859 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 5,625 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00339859 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 5,625 participants
- Enrollment target
Study Summary
The Laboratory of Human Carcinogenesis and the Pharmocogenetics Section of the Genetic Epidemiology Branch will conduct a lung cancer case-control study in Baltimore, Maryland. The primary hypothesis of the study is to determine if mutagen sensitivity, p53 induction and apoptosis in cultured lymphocytes will be predictive of lung cancer risk. While there are some studies that examine mutagen sensitivity, none of these assays has been well-studied in an epidemiological setting. Because of methodological issues described herein, and the proposed development of new assays, this study will be viewed as a pilot and therefore hypotheses generating. The design of this molecular epidemiology study has been specifically developed to test the reliability and validity of the mutagen sensitivity assay, where a case-control study is needed to assess the possibility of case bias (i.e., results vary due to the concurrent presence of lung cancer rather than risk). Importantly, this protocol will establish a resource that will allow for the validation of these assays and also for the study of other biomarkers and gene-environment interactions, especially those related to DNA repair. Th secondary goals of this study are to 1) demonstrate gene-neuro-behavioral interactions for smoking addiction in controls and 2) assess the relationship of sex-steroid metabolism an and estrogen exposure to lung cancer risk. Cases will have histologically confirmed lung cancer and reside in Baltimore an and surrounding areas. They will be identified through six hospitals in Baltimore. Cases will be recently diagnosed and blood will be collected prior to chemotherapy or radiation therapy. Because of this requirement to obtain samples before treatment (or for surgical cases at least two months after surgery), we recognize that case ascertainment will be reduced, but critical data to assess differences between eligible and ineligible subjects will be collected through tumor registries. Two control groups
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,625 participants |
| Start Date | 1995-06-02 |
| Est. Completion | 2020-05-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00339859
The ClinicalTrials.gov registry entry for NCT00339859 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 5,625 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00339859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00339859 about?
NCT00339859 is a clinical study titled "DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer". The Laboratory of Human Carcinogenesis and the Pharmocogenetics Section of the Genetic Epidemiology Branch will conduct a lung cancer case-control study in Baltimore, Maryland. The primary hypothesis of the study is to determine if mutagen sensitivity, p53 induction and apoptosis in cultured lymphoc...
What is the current status of trial NCT00339859?
This trial is currently completed. The enrollment target is 5,625 participants. The study started on 1995-06-02. Estimated completion is 2020-05-06.
Who is sponsoring clinical trial NCT00339859?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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