Actively Recruiting
Screening and Identification of Plasma Biomarkers for Early Diagnosis of Transplant-associated Thrombotic Microangiopathy Using Proteomics and Metabolomics
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
500
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying plasma biomarkers to improve the early diagnosis of transplant-associated thrombotic microangiopathy (TA-TMA), a serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). This study aims to find molecules that can accurately diagnose and predict TA-TMA, especially in adults with malignant blood diseases like acute leukemia. The research will also evaluate whether current biomarkers can predict TA-TMA occurrence and patient survival. Participants will be part of a prospective study cohort enrolling patients undergoing allo-HSCT. Blood and urine samples will be collected at fixed times after transplantation to analyze markers such as SC5b-9, urine protein to creatinine ratio, lactate dehydrogenase, blood counts, and schistocytes. The study will use proteomics and metabolomics technologies to identify new plasma warning biomarkers for early TA-TMA detection and establish a clinical database and biobank for future research. During the study, participants will undergo regular laboratory tests on peripheral blood and urine samples to monitor TA-TMA-related biomarkers. Researchers will collect clinical data and biological samples continuously. The main outcomes measured are plasma biomarkers predicting TA-TMA from transplantation until onset, and one-year survival of TA-TMA patients. Secondary outcomes include mortality without relapse up to two years after transplantation. The study will monitor participants from transplantation through follow-up periods to gather comprehensive data on TA-TMA progression and outcomes.
CONDITIONS
Brief Title
Identification of Plasma Biomarkers for Early Diagnosis of Transplant-associated Thrombotic Microangiopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a hematologic disease such as leukemia, myelodysplastic syndromes, or lymphoma confirmed by appropriate methods
- Undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Age 14 years or older
- Signed informed consent by the patient, a legal guardian, or immediate family member before study start
You will not qualify if you...
- Missing or lost follow-up of key clinical data
- Failure to collect plasma samples at specific time points after transplantation
- Plasma sample collection later than the onset date of thrombotic microangiopathy
- Occurrence of thrombotic microangiopathy later than 180 days after transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 180 days after transplantation
Participants who undergo allogeneic hematopoietic stem cell transplantation are observed with collection of clinical data and plasma samples at fixed testing time points to identify early warning biomarkers of transplant-associated thrombotic microangiopathy (TA-TMA).
Regular plasma sample collections and clinical assessments at scheduled intervals
Duration - Up to 1 to 2 years after transplantation
Participants are followed for survival and mortality outcomes after transplantation.
Follow-up visits to assess survival and non-relapse mortality
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
W
Wenbin Cao
E
Erlie Jiang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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