Biomarker Identification for aGVHD After Allogeneic Stem Cell Transplantation: a Multiple Center Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- incidence of grade II-IV aGVHD
Study Overview
Brief Summary
This is a prospective study in patients receiving allogeneic stem cell transplantation. The blood samples on Day-14, -7, 0 and every 7 days until D100 were collected together with clinical data. In the final analysis, cytokines and biomarkers analysis will be carried out and compared between patients in No aGVHD and grade II-IV aGVHD.
Detailed Description
This is a prospective study, observation study in patients receiving allogeneic stem cell transplantation in 4 BMT centers in Shanghai. The blood samples (on Day-14, -7, 0 and every 7 days until D100) and clinical data will be collected. In the final analysis, a panel of cytokines and biomarkers analysis of serial blood samples will be carried out and compared between patients with no aGVHD and grade II-IV aGVHD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients undergoing allogeneic stem cel transplantation
- •with informed consent
- •patients survived without aGVHD or relapse and patients with development of grade II-IV aGVHD
Exclusion Criteria
- •patients with blood sample and clinical data not available
Outcomes
Primary Outcomes
incidence of grade II-IV aGVHD
Time Frame: 100 days after allogeneic stem cell tansplantation
clinical diagnosis and grade of aGVHD
Secondary Outcomes
No secondary outcomes reported
Investigators
Jiong HU
Deputy director, department of hematology, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine