Identification of Plasma Biomarkers for Early Diagnosis of Transplant-associated Thrombotic Microangiopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-70
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 14 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.

Disqualifiers

1. Missing or lost follow-up of key clinical data

2. failure to collect plasma samples at specific time points after transplantation

3. Plasma sample collection time later than the onset date of TMA

4. TMA occurrence time later than 180 days after transplantation

Trial population

This study will include patients aged 14 years and older who have undergone allogeneic hematopoietic stem cell transplantation for hematologic disorders. Complement, blood smear, renal function, and complete blood count tests at specified time points will be conducted to assess the patients' health status. The investigators anticipate enrolling a minimum of 300 patients and will calculate the incidence rate of TA-TMA according to international diagnostic standards.Based on subsequent occurrences of TATMA in patients, the study population will be categorized into two groups: the TATMA occurrence group and the non-TATMA occurrence group.The objective of this study is to gain insights into the potential role of complement testing in TA-TMA

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

plasma biomarkers to predict TA-TMA

By matching the TMA group with the control group, we aim to identify plasma biomarkers that can predict the early onset of TMA.

Time frame
from transplantation to the onset of TATMA
2

the survival of patients with TATMA

the 1-year OS of patients with TATMA

Time frame
1-year after transplantation

Secondary outcomes

1

non-relapse mortality

the non-relapse mortality for patients

Time frame
one or two years after transplantation

Other outcomes

Sponsors and contacts

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