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Tissue-resident Immune Cell Subsets in aGVHD

NCT ID: NCT06708507

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-16

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Acute Graft-versus-Host Disease Hematopoietic Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Grade 3-4 aGVHD patients

No interventions assigned to this group

Grade 1-2 aGVHD patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily sign the informed consent form;
2. Age 16-65 years old
3. Clinically diagnosed with GVHD for the first time/receiving GVHD treatment.

Exclusion Criteria

1. Have a history of other tumors
2. With poor compliance or mental disorders
3. Infected with HIV and HCV
4. With uncontrolled HBV infection
5. With other autoimmune diseases
6. Those who are judged by the researcher to be unsuitable to participate in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hua Jin

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Other (Non U.s.), China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yiming Sun

Role: CONTACT

[email protected]
+86 13917802810

Facility Contacts

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Yiming Sun

Role: primary

[email protected]

Other Identifiers

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NFEC-2024-084

Identifier Type: -

Identifier Source: org_study_id