Chronic Graft Versus Host Disease in Eye
Conditions
Brief summary
This study is a multicenter, prospective, observational cohort study designed to enroll a total of 340 patients undergoing allogeneic hematopoietic stem cell transplantation. Through comprehensive evaluations by hematology departments, ophthalmology departments, and patient-reported outcomes, the study aims to assess patient-reported outcomes, overall incidence, risk factors, and other clinical outcomes in patients with chronic ocular graft-versus-host disease following allogeneic hematopoietic stem cell transplantation.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥14 years, both genders eligible; * First allogeneic hematopoietic stem cell transplantation; * 100 days post-transplantation, with donor hematopoietic stem cell engraftment confirmed; * The subject or their legally authorized representative has provided full informed consent, signed the informed consent form, and is willing to complete subsequent follow-up visits
Exclusion criteria
* Preexisting moderate-to-severe ocular surface disease prior to transplantation; * Active ocular infection; * Presence of other ocular conditions that, in the opinion of the ophthalmologist, may significantly affect the diagnosis of chronic ocular graft-versus-host disease, the evaluation of ocular surface parameters, or the completion of long-term follow-up; * Patients with active hematologic malignancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NEI-VFQ-25 scale | Two years after HSCT | The NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25) is a 25-item, vision-specific patient-reported outcome measure. It assesses the impact of visual impairment on health-related quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L | Two years after HSCT | The EQ-5D-5L is a standardized, generic health status measure developed by the EuroQol Group. It is designed for self-completion and is widely used in clinical and economic evaluations. |
| Lee GVHD scale | Two years after HSCT | The Lee Chronic GVHD Symptom Scale is a patient-reported outcome (PRO) measure developed to assess the symptom burden of chronic graft-versus-host disease (cGVHD) |
| FACT-BMT | Two years after HSCT | The FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) is a patient-reported outcome (PRO) measure designed to assess health-related quality of life (HRQoL) in patients undergoing bone marrow or hematopoietic stem cell transplantation |
Countries
China
Contacts
CONTACTChuanhe Jiang
Outcome results
None listed