Chronic Graft Versus Host Disease in EyeNCT07794800
Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease
An observational study of Chronic Graft Versus Host Disease in Eye, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease in Eye
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients after all-HSCT
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Chuanhe Jiang, 0086-021-64370045, jch12191@rjh.com.cn
About this study
Official title: A Multicenter, Prospective, Non-Interventional Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation - The Bright Study
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.
- Conditions
- Chronic Graft Versus Host Disease in Eye
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years after HSCT
Secondary outcomes (3)
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.
Measured: Two years after HSCT
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)
Measured: Two years after HSCT
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
Measured: Two years after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host Disease in EyeStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794800
- Sponsor's protocol ID
- RJ-BMT-2026374
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-Interventional Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation - The Bright Study
- ClinicalTrials.gov ID
- NCT07794800
- Acronym / sponsor ID
- RJ-BMT-2026374
- Conditions
- Chronic Graft Versus Host Disease in Eye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after all-HSCT
Key inclusion criteria (4 listed)
- Age ≥14 years, both genders eligible;
- First allogeneic hematopoietic stem cell transplantation;
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NEI-VFQ-25 scale
Time frame: 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
3 secondary outcomes
EQ-5D-5L
Time frame: Two years after HSCT
Lee GVHD scale
Time frame: Two years after HSCT
FACT-BMT
Time frame: Two years after HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Graft Versus Host Disease in Eye, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuanhe Jiang (0086-021-64370045, jch12191@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEI-VFQ-25 scale (time frame: Two years after HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.