Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients after all-HSCT
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
NEI-VFQ-25 scale
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
Time frame
Two years after HSCTSecondary outcomes
1
EQ-5D-5L
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.
Time frame
Two years after HSCT2
Lee GVHD scale
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)
Time frame
Two years after HSCT3
FACT-BMT
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
Time frame
Two years after HSCTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov