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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT01441089
Collaborator
(none)
1,000
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 1,000 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 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition
    Actual Study Start Date :
    May 21, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    1/ Patients with cancer, other tumors, or possible genetic tumor

    Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials

    Outcome Measures

    Primary Outcome Measures

    1. Obtain and analyze the genomic DNA from patients with cancer, other tumors, or possible genetic tumor predisposition syndromes on a therapeutic clinical trial. [duration of study]

      to determine the association between SNP parameters and clinical response and/or toxicity from genomic DNA extracted from patient samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in NIH intramural research program therapeutic trials .

    Ability of patient to understand and be willing to sign the informed consent document.

    Must be greater than or equal to 18.

    EXCLUSION CRITERIA:

    N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: William D Figg, Pharm.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01441089
    Other Study ID Numbers:
    • 110242
    • 11-C-0242
    First Posted:
    Sep 27, 2011
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Jun 14, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022