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A multicenter, longitudinal real-world study on symptom burden, health-related quality of life, and diagnosis and treatment status in patients with chronic graft-versus-host disease (cGVHD)

A multicenter, longitudinal real-world study on symptom burden, health-related quality of life, and diagnosis and treatment status in patients with chronic graft-versus-host disease (cGVHD)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123527
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Chronic graft-versus-host disease

Interventions

Patients with chronic Chronic graft-versus-host disease:None

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) for a hematologic disease; 2.Diagnosed with cGVHD during the follow-up period by an outpatient physician. (The diagnosis of cGVHD relies primarily on clinical manifestations, based on the diagnostic signs outlined in the National Institutes of Health (NIH) Consensus Criteria, as detailed in Appendix Tables 1 and 2); 3. Self-reports experiencing active cGVHD symptoms; 4.Aged >=16 years and <=75 years, and possesses basic literacy and comprehension skills; 5.Volunteers to participate in this study, agrees to the 6-month follow-up, and is able to cooperate with the follow-up personnel.

Exclusion criteria

Exclusion criteria: 1. Incomplete records of transplantation-related information or inability to obtain the allo-HSCT medical records from the external hospital where the procedure was performed; 2. History of psychiatric disorders, experience of major life events, or history of insomnia either before or after transplantation; 3. Anticipated inability to complete the 6-month follow-up (e.g., due to excessive geographical distance, planned relocation, or poor compliance).

Design outcomes

Primary

MeasureTime frame
Change in the Lee Symptom Scale (LSS) score from baseline to 6 months.;

Secondary

MeasureTime frame
Cumulative incidence of treatment-related adverse events within 6 months;;Response rate of chronic GVHD at 6 months;Improvement from baseline in SF-36, FACT-BMT, and EQ-5D-5L scores at 6 months;Incidence and primary reasons for protocol adjustments during the treatment period;

Countries

China

Contacts

Public ContactZhang Xi

The Second Affiliated Hospital of the Army Medical University

zhangxxi@sina.com+86 23 68763198

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026