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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Liver biopsies will be collected from participants undergoing hepatic surgery."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for the best source of a person's own DNA for tests that help guide drug dosing after a stem cell transplant from a donor. It also tests whether the transplant changes how the liver breaks down drugs. It is for adults who will donate or receive stem cells in an NIH Clinical Center trial.

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 received allogeneic HSCT. Eligibility: People ages 18 years and older who are enrolled on a clinical trial at the NIH Clinical Center under which they will donate or receive an allogeneic HSCT. Design: DNA is collected prior to HSCT and for two years after HSCT. Blood will be collected and skin fibroblast cell lines will be established prior to HSCT to serve as a reference genome. Blood, buccal cells, skin, and hair will be monitored for the development of mixed chimerism via detection of short tandem repeats. Liver biopsies will be collected from participants undergoing hepatic surgery. Pharmacoscan arrays will be conducted to determine which samples are useful for pharmacogenetic testing in participants who receive allogeneic HSCT. A probe drug cocktail will be administered pre- and post-HSCT to determine if transplantation alters the metabolic phenotype of liver enzymes. ...

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Be in an NIH Clinical Center trial in which you will donate or receive stem cells for a transplant from a donor.
  • The donor and the person receiving the transplant must join this study together.
  • Be able to understand the study and willing to sign a form agreeing to take part.

Who can't join

  • Donors whose transplant recipient does not join the study.
  • Have had a stem cell transplant from a donor before.
  • Have a history of a mental health disorder that may make it hard to follow study rules.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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

Study sites (1)

MD