Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 antitumor agents 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, pharmaceutical agents. Objectives: To obtain and analyze the genomic DNA from patients with cancer, other tumors, and tumor predisposition syndromes 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 pharmaceutical 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 NIH Intramural Research Program (IRP) therapeutic clinical trials. Design: Exploratory study with a planned accrual of 1,100 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 Pharmacoscan platform (Thermo). 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, other tumors, and tumor predisposition syndromes often receive multiple agents to manage side effects and co-morbidities. The association between variants in Pharmacoscan-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.

Official Title
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Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition

Conditions
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Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Lymphoma

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in NIH intramural research program therapeutic trials. Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document. Age >= 3 years old EXCLUSION CRITERIA: N/A

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1/ Patients with cancer, other tumors, or possible genetic tumor<br>Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain and analyze the genomic DNA from patients with cancer, other tumors, or possible genetic tumor predisposition syndromes on a therapeutic clinical trial. | to determine the association between SNP parameters and clinical response and/or toxicity from genomic DNA extracted from patient samples | duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Clinical Outcome, Drug Metabolism and Transport, Natural History, Cancer