Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02706652 |
| Other study ID # |
160076 |
| Secondary ID |
16-C-0076 |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2018 |
| Est. completion date |
December 1, 2026 |
Study information
| Verified date |
July 28, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
