NCT06708507

Brief Summary

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 ).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 17, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 17, 2024

Last Update Submit

November 25, 2024

Conditions

Acute Graft-versus-Host DiseaseHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Association between tissue-resident Immune cell subsets in organ and acute graft-vs-host disease (aGVHD) outcomes.

    Measure the number/proportion of resident T,B and macrophage cell subsets in the main organ of aGVHD(skin,intestine and liver).

    100days

Secondary Outcomes (2)

  • Association between tissue-resident Immune cell subsets in organ and overall survival(OS).

    100days

  • Association between tissue-resident Immune cell subsets in organ and disease-free survival (DFS)

    100days

Study Arms (2)

Grade 3-4 aGVHD patients

Grade 1-2 aGVHD patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients develop acute graft-versus-disease after hematopoietic stem cell transplantation.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Other (Non U.s.), 510000, China

RECRUITING

Study Officials

  • Hua Jin

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiming Sun

CONTACT

+86 139178028101224940802@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
100 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 27, 2024

Study Start

November 16, 2024

Primary Completion

February 15, 2025

Study Completion

May 31, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)