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Thrombotic MicroangiopathiesNCT06102694

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

An observational study of Thrombotic Microangiopathies and Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn about plasma biomarkers of diagnosed transplant-associated thrombotic microangiopathy (TA-TMA) in patients undergoing transplantation. Read more about this study

Who is it for?
Ages 14 to 70 years
How many people
500 participants
Where
1 siteChina
Study dates
16 Nov 2023to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study 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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenbin Cao contact

15620820820

caowenbin@ihcams.ac.cn

Erlie Jiang contact

+86-15122538106

jiangerlie@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin

    ErLie Jiang

    Recruiting

Other trials in China

About this study

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.

Read the detailed description

Transplant-associated thrombotic microangiopathy (TA-TMA) is a commonly serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). As the diagnostic criteria are not standardized, the incidence of TA-TMA has been reported in the literature to be 0.5%-64%. TA-TMA has an insidious onset, diverse clinical manifestations, rapid progression, limited therapeutic options, and a poor prognosis, with a mortality rate of 60%-90%. The exact pathogenesis of TA-TMA is not yet fully understood. Markers of endothelial damage such as thrombomodulin (TM), plasminogen activator inhibitor-1(PAI-1), intercellular adhesion molecule-1(ICAM-1), and soluble membrane attack complex (sC5b-9) may have predictive roles, but there is a lack of large-scale prospective clinical studies to confirm it. The emergence of multi-omics technologies has brought biomarker research into the high-throughput stage. However, proteomics and metabolomics biomarkers have not been reported in TA-TMA research. In this study, the investigors will establish the first prospective study cohort for screening early warning biomarkers of TA-TMA in China, collect transplantation-related clinical data, and collect plasma serial samples from post-transplantation patients, which are expected to obtain new biomarkers that can be used in the early diagnosis of TA-TMA through the combined analysis of proteomics and metabolomics.

The contents of this study are as follows:

  1. Establish the first prospective study cohort for screening TA-TMA early warning biomarkers in China. Patients will be enrolled continuously who undergo allo-HSCT in order to build a prospective study cohort to search for clinical phenotypes related to the occurrence, evolution, or prognosis of TA-TMA, and to excavate the risk factors of TA-TMA, prognostic factors, etc. Collect complete transplantation-related clinical data, and plasma serial samples at fixed testing time points. SC5b-9, urine protein to creatinine ratio, lactate dehydrogenase, blood routine, schistocytes will be detected at regular times.
  2. According to the diagnostic criteria of TA-TMA, TA-TMA patients and 1:1 matched non-TA-TMA patients will be screened, and the training set (30 cases each) and validation set (10 cases each) will be established respectively. Plasma warning biomarkers with high sensitivity, stability, and accuracy will be screened and identified from the large amount of data by proteomics and metabolomics technologies.
  3. intending to utilize the opportunity of this clinical study to collect clinical data and biological samples from allo-HSCT patients, establish a clinical database and biological samples bank for TA-TMA disease, and provide sample support for subsequent translational research.
Keywords
TA-TMA, Hematopoietic Stem Cell Transplantation
Medical subject headings
Thrombotic Microangiopathies

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from transplantation to the onset of TATMA

  2. the survival of patients with TATMA

    the 1-year OS of patients with TATMA

    Measured: 1-year after transplantation

Secondary outcomes (1)

  1. non-relapse mortality

    the non-relapse mortality for patients

    Measured: one or two years after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start16 Nov 2023
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06102694
Sponsor's protocol ID
QTJC2023036
Status last verified
Dec 2024
First submitted
22 Oct 2023
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guo W, Chen S, Zhang X, Xu M, Zhang X, Wang J, Zheng Y, Shen Y, Liu Q, Ni X, Lv M, Zhang T, Shi Y, Wang F, Zhao X, Wei J, Zhang R, Chen X, Cao Y, Li Y, Mu Y, Pang A, Han M, Zhu G, Cao W, Jiang E. EASIX and sC5b-9 for early identification of adults at high risk of developing TA-TMA after allo-HCT. Bone Marrow Transplant. 2026 Jul 24. doi: 10.1038/s41409-026-02994-y. Online ahead of print.

    PubMed 42493573

Questions about this trial

What is this clinical trial studying?

An observational study of Thrombotic Microangiopathies and Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbin Cao (15620820820, caowenbin@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

plasma biomarkers to predict TA-TMA (time frame: from transplantation to the onset of TATMA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06102694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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