Actively Recruiting

Age: 18Years +
All Genders
ID04689750

Impact of Donor Clonal Haematopoiesis of Indeterminate Potential (CHIP) on Recipient Outcome Following Allogeneic Haematopoietic Stem Cell Transplantation (Allo-HSCT)

Led by The University of Hong Kong · Updated on 2022-10-04

850

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the impact of donor clonal hematopoiesis of indeterminate potential (CHIP) on the long-term outcomes of recipients who undergo allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to understand the association between gene mutations in donors and how these may affect outcomes such as graft function, immune response, graft versus host disease, relapse, and survival. The research is conducted as a single-center prospective and retrospective cohort study at Queen Mary Hospital, Hong Kong. The study collects genetic information from donors at the time of peripheral blood stem cell or bone marrow donation, and from recipients at multiple time points after transplantation, including 1 month, 6 months, 12 months, and at any relapse or leukemia occurrence. Gene mutations and gene fusions are analyzed using next-generation sequencing and nanopore long-read sequencing technology. Data collection occurs through routine clinical visits and medical record reviews in a prospective, partial prospective/retrospective, or retrospective manner. Participants are followed regularly with data collected at donation, transplantation, and every six months post-transplant until death or study end. Researchers monitor outcomes including overall survival, progression-free survival, acute and chronic graft versus host disease, leukemia of donor origin, and cardiac and pulmonary complications over five years. The study involves detailed genetic profiling and long-term observation to assess how donor gene mutations influence recipient health after allogeneic HSCT.

CONDITIONS

Brief Title

Donor CHIP and Allogeneic HSCT Outcome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 18 year or above
  • Donor and recipient of allogeneic hematopoietic stem cell transplantation (allo-HSCT)
  • Provided signed written informed consent for use of clinical data and specimens for genetic analysis in prospective or partial prospective/retrospective cases
  • Previously provided written informed consent authorizing storage and use of archived specimens for retrospective cases
Not Eligible

You will not qualify if you...

  • Donors for autologous peripheral blood stem cell or bone marrow stem cell transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At time of donation and up to 12 months post-transplant

Participants provide blood or bone marrow samples for genetic profiling using next-generation sequencing at the time of stem cell donation and following transplantation.

1 visit at donation and 3 additional visits post-transplant

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored through routine clinical visits and medical record reviews for up to 5 years to assess survival and complications following transplantation.

Visits at 1 month, 6 months, 12 months post-transplant, and every 6 months thereafter

Trial Site Locations

Total: 1 location

1

The University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

H

Harinder Gill, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Engraftment of rare, pathogenic donor hematopoietic mutations in unrelated hematopoietic stem cell transplantation.

Wing Hing Wong, Sima Bhatt, Kathryn Trinkaus...

https://pubmed.ncbi.nlm.nih.gov/31941826