Tissue-resident Immune Cell Subsets in aGVHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Graft-versus-Host Disease, Hematopoietic Stem Cell Transplantation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study on the Correlation Between Tissue-resident Immune Cell Subsets and Graft-versus-host Disease Following Hematopoietic Stem Cell Transplantation.
Overview
This is a prospective study investigating the role of tissue-resident immune cell subsets in the occurrence and progression of graft-versus-host disease following hematopoietic stem cell transplantation. Approximately 40 subjects(including 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients ).
Detailed description
This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2024.11 to 2025.02.It is planned to enroll 40 subjects, divided into 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients. No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate. All recipients will be followed for aGVHD evaluation,overall survival(OS) ,disease-free survival (DFS). aGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.
Primary outcome measures
- Association between tissue-resident Immune cell subsets in organ and acute graft-vs-host disease (aGVHD) outcomes. [Time frame: 100days]
Secondary outcome measures (2)
- Association between tissue-resident Immune cell subsets in organ and overall survival(OS). [Time frame: 100days]
- Association between tissue-resident Immune cell subsets in organ and disease-free survival (DFS) [Time frame: 100days]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form;
- Age 16-65 years old
- Clinically diagnosed with GVHD for the first time/receiving GVHD treatment.
Exclusion criteria
- Have a history of other tumors
- With poor compliance or mental disorders
- Infected with HIV and HCV
- With uncontrolled HBV infection
- With other autoimmune diseases
- Those who are judged by the researcher to be unsuitable to participate in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanfang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT06708507 · NFEC-2024-084