Impact of donor gene mutations on outcomes after stem cell transplantation
Impact of Donor Clonal Haematopoiesis of Indeterminate Potential (CHIP) on Recipient Outcome Following Allogeneic Haematopoietic Stem Cell Transplantation (Allo-HSCT)
This study is testing how gene mutations in stem cell donors affect the health and recovery of patients receiving their transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04689750 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of donor clonal hematopoiesis on the long-term outcomes of recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It involves both prospective and retrospective data collection from donors and recipients at Queen Mary Hospital in Hong Kong. The study will analyze genetic profiles through next-generation sequencing to determine the association between donor gene mutations and recipient outcomes, including graft function and disease relapse. Data will be collected at various time points, including before and after transplantation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are both donors and recipients of allogeneic HSCT.
Not a fit: Patients receiving autologous stem cell transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of how donor genetic factors influence transplant outcomes, potentially leading to better patient management.
How similar studies have performed: While studies on donor genetic factors in HSCT are ongoing, this specific focus on donor clonal hematopoiesis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult aged 18 year or above 2. Donor and recipient of allo-HSCT 3. In prospective and partial prospective/retrospective case, subjects who have provided a signed written informed consent. In retrospective case, subjects who had provided a previously signed written informed consent on: 1. voluntary provision of clinical data, and 2. voluntary provision of archived/remaining specimens for genetic analysis, and 3. authorizing storage and usage of archived/remaining specimens for any further analysis Exclusion Criteria: 1\. Autologous peripheral blood stem cells or bone marrow stem cell donors for autologous HSCT
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Harinder Gill, MD — The University of Hong Kong
- Study coordinator: Harinder Gill, MD
- Email: gillhsh@hku.hk
- Phone: +852 22554542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.