Collection of Blood From Cancer Patients for Genetic Analysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01441089
First received: September 24, 2011
Last updated: January 16, 2015
Last verified: December 2014
  Purpose

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.

Condition
Prostate Cancer
Breast Cancer
Lung Cancer
Ovarian Cancer
Lymphoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Blood From Patients With Cancer for Analysis of Genetic Differences in Drug Disposition

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Obtain and analyze the genomic DNA from patients with cancer on a therapeutic clinical trial. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2011
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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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:

Not applicable

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441089

Contacts
Contact: Tristan M Sissung (301) 594-5606 sissungt@mail.nih.gov
Contact: William D Figg, Pharm.D. (301) 402-3622 wdfigg@helix.nih.gov

Locations
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      
Sponsors and Collaborators
Investigators
Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01441089     History of Changes
Other Study ID Numbers: 110242, 11-C-0242
Study First Received: September 24, 2011
Last Updated: January 16, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pharmacogenetics
Pharmacokinetics
Pharmacodynamics
Clinical Outcome
Drug Metabolism and Transport
Cancer

ClinicalTrials.gov processed this record on May 21, 2015