Prospective Screening for Patient-Specific Genotypes and Phenotypes That Influence Drug Dosing and Trial Selection in Cancer Patients

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02706652
Collaborator
(none)
900
1
102.3
8.8

Study Details

Study Description

Brief Summary

Background:

People's genetic markers and other genetic characteristics can affect their response to drug therapy. Researchers want to screen people for these markers and characteristics. They want to do this before the people are screened for studies at the National Cancer Institute. That should save time that can be lost when people go through the whole screening for a study only to find out they cannot join. The data collected may also be used to select the proper dose of anticancer agents that are being studied.

Objective:

To screen people for genetic markers and/or baseline characteristics. These will be used to determine if they can enroll in a clinical trial. They may also be used to select the proper dose of anticancer agents that are being tested.

Eligibility:

Adults 18 and older who are being considered for or being treated in a National Cancer Institute study

Design:

Participants will have their blood drawn for genetic tests.

Some participants will have a cheek swab.

Participants genetic data will be stored for future research. It could be shared with other researchers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background:

    Genetic sequence of drug-metabolizing enzymes, transporters/receptors, transcription factors, drug targets, and patient baseline characteristics often affect an individual s response to drug therapy. Expression of such genes is also influenced by the epigenome and regulation by a variety of other factors: RNA expression, protein expression, disease state, comorbidities, concomitant therapies, etc. Therefore, inter-patient variability in drug pharmacokinetics and outcome is often a function of these factors.

    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 variability in pharmacokinetics, pharmacodynamics, clinical outcome, and toxicity are often noted. Many of these differences are potentially clinically actionable and depend on the aforementioned markers.

    Objectives:

    To screen patients for genomic markers, epigenomic markers, RNA markers, protein markers, and/or baseline characteristics that are used inform either enrollment in therapeutic clinical trials or dose selection of investigational anticancer agents.

    Eligibility:

    All individuals seeking enrollment on National Cancer Institute clinical trials that include a priori assessment of a patients genome, epigenome, proteome, or baseline characteristics as eligibility criteria for enrollment or dose selection.

    Design:

    This study will be used as a screening protocol to enroll patients for a priori screening that is necessary for inclusion in IRB-approved clinical trials taking place at the NCI.

    As the rationale for ascertaining the status of a marker prior to study inclusion will be presented in the associated clinical trial, the present study will be amended on a case-by-case basis.

    The accrual ceiling for this study is 900 patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Screening for Patient Specific Genotypes and Phenotypes That Influence Drug Dosing and Trial Selection in Cancer Patients
    Actual Study Start Date :
    May 22, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    all patients

    all eligible patients

    Outcome Measures

    Primary Outcome Measures

    1. To provide pharmacogenomic and/or biomarker analysis to support enrollment of patients on clinical trials that require such markers prior to enrollment. [duration of study]

      Collection of 6 mL of peripheral blood to analyzed via DMET Plus kit for pathway genotype of enzymes and transporters with putative relevance for the drug of interest.

    Eligibility Criteria

    Criteria

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

    • Any patient who is being evaluated for and/or treated on an IRB-approved protocol at the National Cancer Institute.

    • Age >18 years.

    • Ability of subject to understand and the willingness to sign a written informed consent document.

    EXCLUSION CRITERIA:
    • A patient will be excluded if there is an insufficient quality or quantity of sample available to perform the assay and no further sample can be drawn in order to re-assess the status of a genetic or biomarker.

    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:
    NCT02706652
    Other Study ID Numbers:
    • 160076
    • 16-C-0076
    First Posted:
    Mar 11, 2016
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Nov 2, 2021
    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)

    Study Results

    No Results Posted as of Jul 7, 2022