Collection of Blood From Cancer Patients for Genetic Analysis
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/27/2019 |
| Start Date: | May 21, 2012 |
| Contact: | Julie C Barnes, R.N. |
| Email: | barnesjk@mail.nih.gov |
| Phone: | (240) 760-6044 |
Collection of Blood From Patients With Cancer for Analysis of Genetic Differences in Drug Disposition
Background:
- 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.
Objectives:
- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer
treatment.
Eligibility:
- Individuals with cancer who are being treated at the National Cancer Institute.
Design:
- 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.
- 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.
Objectives:
- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer
treatment.
Eligibility:
- Individuals with cancer who are being treated at the National Cancer Institute.
Design:
- 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.
Background
- 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.
Objectives
- 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.
Eligibility
- All individuals enrolled on IRB approved therapeutic clinical trials at the National Cancer
Institute.
Design
- 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.
- 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.
Objectives
- 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.
Eligibility
- All individuals enrolled on IRB approved therapeutic clinical trials at the National Cancer
Institute.
Design
- 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.
- INCLUSION CRITERIA:
Cancer patients currently enrolled in a Medical Oncology Branch IRB approved therapeutic
trials at the National Cancer Institute are eligible.
Must be able to understand and willing to sign the informed consent document.
Must be greater than or equal to 18.
EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: (888) NCI-1937
Click here to add this to my saved trials
