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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
This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate 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. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ddPCR MRD positivity |
| ||
| ddPCR MRD negativity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Droplet PCR | Diagnostic Test | Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival (RFS) | The time from the date of treatment to the occurrence of any of the following:
| At Year 2 |
| Non-relapse mortality (NRM) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Zhejiang Medical Colleage Zhejiang University | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38689269 | Derived | 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. |
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| ID | Term |
|---|---|
| D018365 | Neoplasm, Residual |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Assessment of NRM at Year 2
| At Year 2 |
| Overall survival (OS) | Assessment of OS at Year 2 | At Year 2 |
| D020969 | Disease Attributes |