MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse
Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse
1 other identifier
observational
192
1 country
1
Brief Summary
A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedFirst Submitted
Initial submission to the registry
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedAugust 22, 2023
August 1, 2023
3.7 years
August 11, 2023
August 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative incidence of relapse (CIR)
The time from the date of transplantation to disease recurrence: Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
At Year 2
Secondary Outcomes (3)
Relapse-free survival (RFS)
At Year 2
Non-relapse mortality (NRM)
At Year 2
Overall survival (OS)
At Year 2
Study Arms (2)
ddPCR MRD positivity
ddPCR MRD negativity
Interventions
Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period
Eligibility Criteria
Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT
You may qualify if:
- The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring;
- Successful stem cell engraftment
- Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;
- Age 12-70
You may not qualify if:
- Patients who relapsed or died before the first ddPCR monitoring;
- Patients with only germline mutations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
Related Publications (1)
Chen W, Huang J, Zhao Y, Huang L, Yuan Z, Gu M, Xu X, Shi J, Luo Y, Yu J, Lai X, Liu L, Fu H, Bao C, Huang X, Zheng Z, Huang H, Hu X, Zhao Y. Measurable residual disease monitoring by ddPCR in the early posttransplant period complements the traditional MFC method to predict relapse after HSCT in AML/MDS: a multicenter retrospective study. J Transl Med. 2024 Apr 30;22(1):410. doi: 10.1186/s12967-024-05114-w.
PMID: 38689269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 21, 2023
Study Start
January 1, 2018
Primary Completion
August 31, 2021
Study Completion
July 31, 2023
Last Updated
August 22, 2023
Record last verified: 2023-08