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NCT Number: NCT06708507

Tissue-resident Immune Cell Subsets in aGVHD

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 ).

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Key information

Conditions

Acute Graft-versus-host Disease Hematopoietic Stem Cell Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

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

Location status: Recruiting

Location contact

Yiming Sun

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 100days

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

Secondary outcomes

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

    Time frame: 100days

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

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

    Time frame: 100days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yiming Sun

CONTACT

[email protected]

+86 13917802810

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

A Prospective Study on the Correlation Between Tissue-resident Immune Cell Subsets and Graft-versus-host Disease Following Hematopoietic Stem Cell Transplantation.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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