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NCT00341939 · ClinicalTrials.gov registry record
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 484
- Enrollment target
NCT00341939: Completed study, sponsored by National Cancer Institute (NCI).
NCT00341939 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 484 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00341939 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 484 participants
- Enrollment target
Study Summary
This study is a retrospective one, exploring the hypothesis that a person's genotypic makeup may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms, that is, states of being able to assume different forms, that are in drug-metabolizing enzymes, transporters, and receptors may affect a patient's response to drug therapy. To date, there have been limited studies looking at a drug-metabolizing genotype (genetic makeup) or phenotype (result of the genotype's interaction with the environment). However, it is often wondered if the variations in a drug's action, that is, pharmacokinetic effect, come from the genotype phenotype relationship. Participants who entered previous clinical trials at the National Cancer Institute, as approved by the Central Institutional Review Board, may be eligible for this study. Studies for which pharmacokinetic analyses were or are being performed will be the source of the patient population. Genotyping experiments will be performed through genomic DNA isolated from stored frozen serum. The genotyping results will be compared with pharmacokinetic data and clinical outcomes. Clinical data will consist of what is obtained during the course of the principal pharmacokinetic study. The results of the retrospective analyses will provide no direct benefit to the participants.
Primary Outcome
To retrospectively evaluate the association between pharmacokinetic data and polymorphisms in drug-metabolizing enzymes and transporters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2004-09-07 |
| Est. Completion | 2024-06-12 |
What the finished NCT00341939 record still lists
NCT00341939 is an observational study that tracks outcomes without assigning an intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00341939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00341939 about?
NCT00341939 is a clinical study titled "Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data". This study is a retrospective one, exploring the hypothesis that a person's genotypic makeup may be associated with a clinical response or toxic effect to a drug. Genetic polymorphisms, that is, states of being able to assume different forms, that are in drug-metabolizing enzymes, transporters, and ...
What is the current status of trial NCT00341939?
This trial is currently completed. The enrollment target is 484 participants. The study started on 2004-09-07. Estimated completion is 2024-06-12.
Who is sponsoring clinical trial NCT00341939?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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