Clonal hematopoiesis of indeterminate potential and its distinction from myelodysplastic syndromes.
David P Steensma, Rafael Bejar, Siddhartha Jaiswal...
https://pubmed.ncbi.nlm.nih.gov/25931582Actively Recruiting
Led by The University of Hong Kong · Updated on 2022-10-04
850
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Donor CHIP and Allogeneic HSCT Outcome
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
H
Harinder Gill, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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