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Spatiotemporal single-cell mapping and cytokine detection to elucidate the role of immune cell subsets in the occurrence and outcome of oral cGVHD

Spatiotemporal single-cell mapping and cytokine detection to elucidate the role of immune cell subsets in the occurrence and outcome of oral cGVHD

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096750
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft versus-host disease

Interventions

Oral cGVHD:NA
Non-oral cGVHD:NA

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. From December 2024 to December 2026, 18-50 years old patients diagnosed with oral chronic GVHD after allogeneic hematopoietic stem cell transplantation in our center were enrolled as the experimental group, and non-oral chronic GVHD patients after allogeneic hematopoietic stem cell transplantation were enrolled as the control group. 2. Voluntarily participate in this study, and sign the informed consent; 3. without serious damage of vital organs: (1) creatinine =2g/dl; (3) Cardiac ejection index >50%; (4) heme >9g/dL, bilirubin < 2.0mg/dl; 4. Blood routine, liver and kidney function, coagulation routine were normal; 5. No other contraindications to salivary gland biopsy.

Exclusion criteria

Exclusion criteria: 1. There is active bleeding caused by drugs or thrombocytopenia, and clinically uncontrolled active infection; 2. Pregnant or lactating women; 3. Severe heart, kidney or liver dysfunction; 4. Drug-related or other mucosal diseases and oral diseases, diabetes; 5. Inability to understand or follow the study protocol due to clinical symptoms of brain dysfunction or severe mental disease; 6. Patients with severe acute allergic reactions; 7. The investigators considered that other reasons were not appropriate for clinical trials.

Design outcomes

Primary

MeasureTime frame
Salivary glands 10× Genomics Visium space transcriptome specifically expressed genes;Salivary cytokines;Exfoliative cellular components of the oral mucosa;

Countries

China

Contacts

Public ContactXi Zhang

The Second Affiliated Hospital of the Army Medical University

zhangxxi@sina.com+86 138 0831 0064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026