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

NCT06102694 | Recruiting DMC

• 1 other identifier: QTJC2023036
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thrombotic Microangiopathies; Hematopoietic Stem Cell Transplantation

Keywords

TA-TMA; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

• 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.

  from transplantation to the onset of TATMA

• the survival of patients with TATMA

  the 1-year OS of patients with TATMA

  1-year after transplantation

Secondary Outcomes (1)

• non-relapse mortality

  one or two years after transplantation

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \. Diagnosis of a hematologic disease (e.g., leukemia, myelodysplastic syndromes,lymphoma) confirmed by histology or other appropriate diagnostic methods.
• \. undergoing allo-HSCT
• \. Age 14 years or older
• 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.

You may not qualify if:

• \. Missing or lost follow-up of key clinical data
• \. failure to collect plasma samples at specific time points after transplantation
• \. Plasma sample collection time later than the onset date of TMA
• \. TMA occurrence time later than 180 days after transplantation

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood will be collected to reserve plasma and mononuclear cells

MeSH Terms

Conditions

Thrombotic Microangiopathies

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Erlie Jiang

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Cao

CONTACT

15620820820; caowenbin@ihcams.ac.cn

Erlie Jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: November 16, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2024-12

Locations

CN (1)