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Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

Recruitingn/aAges 18 Years - 120 YearsAllNational Cancer Institute (NCI)
NCT06856226 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: After an allogeneic hematopoietic stem cell transplant (HSCT), the donor genome is found in the recipient s circulation and tissues. Post-HSCT recipients may receive a medication in which the dosing needs to be adjusted based on genetic variation. While genes in donor genome may influence dosing and administration of some agents, the majority of established gene-drug pairs in pharmacogenetics are related to expression of metabolic or transporting enzymes located in recipients tissues, often the liver. Determining which genetic variants influence drug disposition in HSCT recipients is complicated by chimerism in samples that are routinely collected for determining genotype. However, chimerism in tissues is poorly studied in this patient population. Objectives: To determine the most reliable host genomic source for pharmacogenetic testing in participants that have receive

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📋 Eligibility rules (as published)
* INCLUSION CRITERIA: * Age \>=18 years * Participants must be enrolled on a clinical trial at the NIH Clinical Center (CC) under which they will donate or receive an allogeneic HSCT. The participant and their donor must enroll together to provide a complete set of samples for analysis. * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Donors are not allowed to enroll without a recipient * Prior allogeneic HSCT * History of psychiatric disorder which may compromise compliance with protocol requirements. * Pregnant and lactating individuals
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What it tests

  • Arm 1
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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