Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
Screening and Identification of Plasma Biomarkers for Early Diagnosis of Transplant-associated Thrombotic Microangiopathy Based on Proteomics and Metabolomics Techniques
The goal of this clinical trial is to learn about plasma biomarkers of diagnosed transplant-associated thrombotic microangiopathy (TA-TMA) in patients undergoing transplantation. The main questions it aims to answer are: whether there are molecules that can accurately diagnose and predict TA-TMA; whether the current biomarkers related to TA-TMA can well predict the occurrence and survival of TA-TMA in adult patients with malignant hematopoietic diseases, for example, acute leukemia. Participants will receive laboratory tests of peripheral blood and urine specimens related to TA-TMA at regular times after transplantation.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 1. Diagnosis of a hematologic disease (e.g., leukemia, myelodysplastic syndromes,lymphoma) confirmed by histology or other appropriate diagnostic methods. - 2. undergoing allo-HSCT - 3. Age 18 years or older - 4.Informed consent must be signed before the start of the study. For participants aged 18 and above, the informed consent should be signed by the patient or their immediate family member. Considering the patient's condition, if it is not favorable for the patient to sign, the informed consent may be signed by a legal guardian or immediate family member of the patient. Exclusion Criteria: - 1. History of prior allogeneic hematopoietic stem cell transplantation - 2. Persistent or active infections including bacterial, fungal and viral infections - 3. Severe organ dysfunction - 4. unable to comply with the study protocol due to other circumstances |
Country | Name | City | State |
---|---|---|---|
China | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Institute of Hematology & Blood Diseases Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The frequency of TA-TMA | diagnostic criteria is based on criteria proposed by Sonata Jodele | 100 days after transplantation | |
Primary | Risk factors for TA-TMA | Find risk factors for patients with TA-TMA | one year after transplantation | |
Primary | levels of sC5b-9 at regular times | to detect the levels of sC5b-9 at regular times after transplantation | before transplantation, 0 days, 14 days, 28 days, 42 days and 60days after transplantation | |
Secondary | overall survival | the overall survival for patients | one or two years after transplantation | |
Secondary | non-relapse mortality | the non-relapse mortality for patients | one or two years after transplantation | |
Secondary | acute graft versus host disease | report the rate of acute graft versus host disease | three months after transplantation |
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