Clinical trial NCT01441089: Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis
Official title: Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Breast Cancer
Lung Cancer
Ovarian Cancer
Lymphoma
Keywords: Pharmacogenetics
Pharmacokinetics
Pharmacodynamics
Clinical Outcome
Drug Metabolism and Transport
Natural History
Cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-09-27
Enrollment: 1100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient enrolled on an IRB approved NIH Intramural Research Program therapeutic clinical trial with cancer, other tumors, or possible genetic tumor predisposition syndromes.

Brief summary: 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: 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Obtain and analyze the genomic DNA from patients with cancer, other tumors, or possible genetic tumor predisposition syndromes on a therapeutic clinical trial.
timeFrame: duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: William D Figg, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: