Collection of Blood From Cancer Patients for Genetic Analysis
- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes.
- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment.
- Individuals with cancer who are being treated at the National Cancer Institute.
- Participants will provide a blood sample for study.
- Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample.
- If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Collection of Blood From Patients With Cancer for Analysis of Genetic Differences in Drug Disposition|
- Obtain and analyze the genomic DNA from patients with cancer on a therapeutic clinical trial. [ Time Frame: Duration of study ]
|Study Start Date:||August 24, 2011|
- Genetic polymorphisms in drug-metabolizing enzymes, transporters/receptors might affect an individual s response to drug therapy.
- Inter-individual differences in efficacy and toxicity of cancer chemotherapy are especially important given the narrow therapeutic index of these drugs.
- During analysis of investigational agents, inter-individual variation in pharmacokinetics and pharmacodynamics (PK/PD) is most often noted. Genetic variation in genes encoding proteins that regulate or mediate the metabolism and transport of drugs often account for some of the wide variation seen in PK/PD, and ultimately the response to, and toxicity from, anticancer agents.
- To obtain and analyze the genomic DNA from patients with cancer on a therapeutic clinical trial.
- To prospectively explore correlations between genetic variants involved in inter-individual differences in drug disposition versus pharmacokinetics, pharmacodynamics, response, and toxicity endpoints in patients receiving anticancer agents.
- To mitigate harm due to treatment with ineffective or toxicity-inducing drugs in patients where gene-drug interactions are established.
- All individuals enrolled on IRB approved therapeutic clinical trials at the National Cancer Institute.
- Exploratory study with a planned accrual of 1,000 patients
- Genomic DNA will be extracted from blood samples collected from patients (patients with leukemia will have cheek swab samples collected) and genotyped using the Affymetrix DMET.
- In cases where patients carry genetic variants that are related to poor outcome or significant toxicity on a given drug, clinical recommendations will be provided where specific instructions are available in the package insert. This will apply to non-anticancer agents as well given that patients with cancer often receive multiple agents to manage side effects and co-morbidities.
- The association between genetic variants in DMET-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441089
|Contact: Tristan M Sissung, Ph.D.||(301) firstname.lastname@example.org|
|Contact: William D Figg, Pharm.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||William D Figg, Pharm.D.||National Cancer Institute (NCI)|