Identifying blood markers for early diagnosis of transplant-related complications
Screening and Identification of Plasma Biomarkers for Early Diagnosis of Transplant-associated Thrombotic Microangiopathy Based on Proteomics and Metabolomics Techniques
This study is trying to find blood markers that can help doctors spot early signs of a serious complication called TA-TMA in patients who have had a stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06102694 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify plasma biomarkers that can accurately diagnose and predict transplant-associated thrombotic microangiopathy (TA-TMA) in patients undergoing hematopoietic stem cell transplantation. The study will collect and analyze blood and urine samples from participants at regular intervals post-transplantation to explore the relationship between specific biomarkers and the occurrence of TA-TMA. By utilizing advanced proteomics and metabolomics techniques, the researchers hope to establish a cohort that can lead to the discovery of new early warning biomarkers for TA-TMA, addressing a significant gap in current diagnostic practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with a hematologic disease and are undergoing allogeneic hematopoietic stem cell transplantation.
Not a fit: Patients with a history of prior allogeneic hematopoietic stem cell transplantation or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and improved management of TA-TMA, potentially reducing mortality rates associated with this condition.
How similar studies have performed: While there is a lack of large-scale prospective studies specifically on TA-TMA, the use of multi-omics technologies for biomarker discovery has shown promise in other areas of medical research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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. Exclusion Criteria: * 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
Where this trial is running
Tianjin
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Erlie Jiang — Chinese Academy of Medical Sciences
- Study coordinator: Wenbin Cao
- Email: caowenbin@ihcams.ac.cn
- Phone: 15620820820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.