Graft Versus Host Disease in EyeNCT06874283
Ocular Complications From Cancer Therapy - Patient Registry and Biobank
An observational study of Graft Versus Host Disease in Eye and Ocular Complications, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to collect data on patients seen at University of Maryland after undergoing cancer therapy. Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graft Versus Host Disease in Eye, Ocular Complications, Inflammatory Dry Eye Disease
- What is being tested?
- Eye exam
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to Apr 2031
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have undergone cancer treatment and in control patients who have not undergone either cancer therapy. The goal of the control patients is to have a direct comparison of 'normal' tear samples as compared to tear/ocular samples from those patients who have undergone cancer treatment.
Who may be able to join
- Adult patients (greater than 18 years of age)
- Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
- Patients who have a history of allogenic HSCT with all stem cell sources including bone marrow, PBSC, cord AND/OR patients with a history of prior cancer therapy including BMT, chemotherapy, and immunotherapy
- Patients will be recruited after their HSCT or cancer therapy at their ophthalmology appointment
- Patients can be included with a history of prior cancer therapy including chemotherapy, BMT, immunotherapy. Prior cancer therapy must be identified and documented.
- The patient must be able to understand and sign and date the informed consent form approved by the IRB.
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- No history of cancer or cancer therapy in the past
- Adult patients (greater than 18 years of age)
- Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
- The patient must be able to understand and sign and date the informed consent form approved by the IRB.
Who cannot join
- Vulnerable populations: neonates, children, prisoners, institutionalized individuals
- Inability or refusal to provide informed consent.
- History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).
- Vulnerable populations: neonates, children, prisoners, institutionalized individuals
- Inability or refusal to provide informed consent.
- History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).
- History of cancer or cancer therapy including chemotherapy, immunotherapy, BMT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stoler Outpatient Cancer Center at the University of Maryland
Baltimore, Maryland, 21201
Sarah Sunshine, MD, 667-214-1292, ssunshine@som.umaryland.edu
About this study
Official title: Registry and Biobank of Patients With a History of Cancer Therapy
The purpose of this study is to collect data on patients seen at University of Maryland after undergoing cancer therapy. Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. Potential subjects will be enrolled from the clinical practice of the investigator at the time of their eye examination visit. A standard of care exam will be performed pertinent to the reason for the visit. In addition to the standard of care exam, certain biological specimens (ocular surface wash, mucocellular material, corneal filaments, impression cytology, and/or blood) will be collected, stored, and analyzed to obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.
Read the detailed description
The objective of this study is to evaluate and study the immunologic changes in patients who undergo cancer therapy, specifically identifying patients who are at risk of developing ocular complications from their cancer therapy such as ocular GVHD and corneal toxicity. By creating a detailed registry and robust biobank of patients' samples, the investigators will have the ability to (1) better define the pathogenesis of the ocular toxicity such as ocular GVHD or corneal keratopathy from cancer immunologics, (2) identify predictive factors for developing ocular complications as a result of cancer therapy. By developing a biobank of patients' samples who have undergone cancer therapy, the investigators will have the ability to evaluate clinical findings and determine factors and markers to better understand the mechanisms corneal disease in these patients. Through this biobank, the investigators would like to gather data on the clinical findings and management of ocular complications in patients who have undergone cancer treatment. Participants will fall into one of two groups: either the the Bone Marrow Transplant/Cancer Therapy group or Control group where they have no previous history of cancer therapy. The intervention in this study will be the eye exam.
- Being tested
- Eye exam
- Keywords
- ocular graft versus host disease, allogenic stem cell transplant, blood cancer, ocular complications, inflammatory dry eye disease, ocular surface disease
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye examProcedure or surgery
Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. A standard of care exam will be performed to the reason for the visit. In addition to the standard of care exam, those in the Cancer Therapy arm will have certain biological samples (tear collection, impression cytology, and/or blood) collected, stored, and analyzed so we may obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Therapy | The intervention administered will be the eye exam and research protocols (e.g. tear collection, impression cytology, and blood collection) Receives: Procedure: Eye exam | |
| Control | The intervention administered will be the standard of care procedures of the eye exam. Receives: Procedure: Eye exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Chronic Ocular Graft Versus Host Disease Severity Score
The International Chronic oGVHD severity score (Ogawa, Y. et al. International Chronic Ocular Graft-vs-Host-Disease (GVHD) Consensus Group: Proposed Diagnostic Criteria for Chronic GVHD (Part I). Sci Rep 3, 3419 (2013). https://doi.org/10.1038/srep03419) is the standard of care for diagnosing and monitoring ocular GvHD. Briefly, this is calculated based on the sum of the patient's Schirmer's severity score (range of 0-3), OSDI severity score (range of 0-3), corneal fluorescein staining severity score (range of 0-3), and conjunctival injection severity score (range of 0-2). This sum ranges from 0 to 11. To diagnose whether a patient has no oGVHD, probable oGVHD, or definite oGVHD, there are two separate scales depending on whether the patient has systemic GVHD or not. Based on the sum of the characteristics, one can diagnose whether or not the patient has oGVHD. Patients are categorized into None, Probable or Definite and the criteria is different based on their systemic GvHD status.
Measured: At the time of intervention (eye exam), between on average 3 months to 5 years post-transplant, but this can also extend up to 10 years post-transplant. The expected average will be 3 years post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start13 May 2025
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host Disease in EyeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874283
- Sponsor's protocol ID
- 24105GCCC
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry and Biobank of Patients With a History of Cancer Therapy
- ClinicalTrials.gov ID
- NCT06874283
- Acronym / sponsor ID
- 24105GCCC
- Keywords
- ocular graft versus host disease, allogenic stem cell transplant, blood cancer, ocular complications, inflammatory dry eye disease, ocular surface disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 13 Mar 2025 (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.
The purpose of this study is to collect data on patients seen at University of Maryland after undergoing cancer therapy. Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. Potential subjects will be enrolled from the clinical practice of the investigator at the time of their eye examination visit. A standard of care exam will be performed pertinent to the reason for the visit. In addition to the standard of care exam, certain biological specimens (ocular surface wash, mucocellular material, corneal filaments, impression cytology, and/or blood) will be collected, stored, and analyzed to obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.
Detailed description
The objective of this study is to evaluate and study the immunologic changes in patients who undergo cancer therapy, specifically identifying patients who are at risk of developing ocular complications from their cancer therapy such as ocular GVHD and corneal toxicity. By creating a detailed registry and robust biobank of patients' samples, the investigators will have the ability to (1) better define the pathogenesis of the ocular toxicity such as ocular GVHD or corneal keratopathy from cancer immunologics, (2) identify predictive factors for developing ocular complications as a result of cancer therapy. By developing a biobank of patients' samples who have undergone cancer therapy, the investigators will have the ability to evaluate clinical findings and determine factors and markers to better understand the mechanisms corneal disease in these patients. Through this biobank, the investigators would like to gather data on the clinical findings and management of ocular complications in patients who have undergone cancer treatment. Participants will fall into one of two groups: either the the Bone Marrow Transplant/Cancer Therapy group or Control group where they have no previous history of cancer therapy. The intervention in this study will be the eye exam.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Therapy | – | Procedure: Eye examThe intervention administered will be the eye exam and research protocols (e.g. tear collection, impression cytology, and blood collection) |
| Control | – | Procedure: Eye examThe intervention administered will be the standard of care procedures of the eye exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone cancer treatment and in control patients who have not undergone either cancer therapy. The goal of the control patients is to have a direct comparison of 'normal' tear samples as compared to tear/ocular samples from those patients who have undergone cancer treatment.
Key inclusion criteria (10 listed)
- Adult patients (greater than 18 years of age)
- Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
- Patients who have a history of allogenic HSCT with all stem cell sources including bone marrow, PBSC, cord AND/OR patients with a history of prior cancer therapy including BMT, chemotherapy, and immunotherapy
- Patients will be recruited after their HSCT or cancer therapy at their ophthalmology appointment
- Patients can be included with a history of prior cancer therapy including chemotherapy, BMT, immunotherapy. Prior cancer therapy must be identified and documented.
Key exclusion criteria (7 listed)
- Vulnerable populations: neonates, children, prisoners, institutionalized individuals
- Inability or refusal to provide informed consent.
- History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).
- Vulnerable populations: neonates, children, prisoners, institutionalized individuals
- Inability or refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye examPrevious medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. A standard of care exam will be performed to the reason for the visit. In addition to the standard of care exam, those in the Cancer Therapy arm will have certain biological samples (tear collection, impression cytology, and/or blood) collected, stored, and analyzed so we may obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis. | Procedure or surgery | Cancer Therapy, Control |
Primary outcome
International Chronic Ocular Graft Versus Host Disease Severity Score
Time frame: At the time of intervention (eye exam), between on average 3 months to 5 years post-transplant, but this can also extend up to 10 years post-transplant. The expected average will be 3 years post-transplant.
The International Chronic oGVHD severity score (Ogawa, Y. et al. International Chronic Ocular Graft-vs-Host-Disease (GVHD) Consensus Group: Proposed Diagnostic Criteria for Chronic GVHD (Part I). Sci Rep 3, 3419 (2013). https://doi.org/10.1038/srep03419) is the standard of care for diagnosing and monitoring ocular GvHD. Briefly, this is calculated based on the sum of the patient's Schirmer's severity score (range of 0-3), OSDI severity score (range of 0-3), corneal fluorescein staining severity score (range of 0-3), and conjunctival injection severity score (range of 0-2). This sum ranges from 0 to 11. To diagnose whether a patient has no oGVHD, probable oGVHD, or definite oGVHD, there are two separate scales depending on whether the patient has systemic GVHD or not. Based on the sum of the characteristics, one can diagnose whether or not the patient has oGVHD. Patients are categorized into None, Probable or Definite and the criteria is different based on their systemic GvHD status.
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 5 Mar 2026.
- Individual participant dataSharing planned: No
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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 Graft Versus Host Disease in Eye and Ocular Complications, run by University of Maryland, Baltimore at 1 site in United States.
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 10 inclusion and 7 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 5 Mar 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 United States. 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 Sarah Sunshine, MD (667-214-1292, ssunshine@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Chronic Ocular Graft Versus Host Disease Severity Score (time frame: At the time of intervention (eye exam), between on average 3 months to 5 years post-transplant, but this can also extend up to 10 years post-transplant. The expected average will be 3 years post-transplant.). 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 5 Mar 2026.