RecruitingNCT04689750

Donor CHIP and Allogeneic HSCT Outcome

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

Sponsor

The University of Hong Kong

Enrollment

850 participants

Start Date

Jan 1, 2021

Study Type

OBSERVATIONAL

Conditions

Clonal Hematopoiesis

Summary

Current data on the impact of donor CHIP on long-term recipient outcome remain largely speculative. Data on the impact of donor CHIP including on allograft function, immunologic dysfunction, graft versus host disease (GVHD), disease relapse and survival across various donor populations are scarce. This is a retrospective-prospective cohort study designed to determine the association between donor gene mutations and outcome following allogeneic HSCT.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Adult aged 18 year or above
Donor and recipient of allo-HSCT
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:
voluntary provision of clinical data, and
voluntary provision of archived/remaining specimens for genetic analysis, and
authorizing storage and usage of archived/remaining specimens for any further analysis

Exclusion Criteria1

\. Autologous peripheral blood stem cells or bone marrow stem cell donors for autologous HSCT

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Interventions

DIAGNOSTIC_TESTNext generation sequencing

Genetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia. Gene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing.