2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD

January 30, 2026 updated by: University of Maryland, Baltimore

2177GCCC: Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease (oGVHD) a Biobank Study

Evaluate and study the immunologic changes to the ocular surface in cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a longitudinal natural history study to evaluate and study the immunologic changes to the ocular surface in cancer patients.

Two groups of subjects will be recruited for the study: 1) Pre-bone marrow transplant cancer patients. They will be evaluated every 3 months for 2 years.2) Normal control patients. They will be evaluated every 6 months for the duration of the study.

During each study visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments, or impression cytology of conjunctiva, blood, or serum) will be collected.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Patricia Lesho
  • Phone Number: 410-328-2577
  • Email: plesho@umm.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Geenebaum Cancer Center, University of Maryland Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Two groups of patients will be invited to participate in the study.

  1. BMT Patients (Study) - Patients prior to receiving a bone marrow transplant will be recruited during their initial intake prior to their BM transplant through the PI's regularly scheduled appointment with these patients.
  2. Controls - patients with no history of eye disease or cancer history.

Description

Inclusion Criteria:

  • Adult patients (≥ 18 years of age) who visit the Eye clinic either in the UMGCCC within the UMD Hospital or the UMD Faculty Physicians Ophthalmology Practice at the UMD Professional Building or satellite locations for initial visits or established visits.
  • The patient must be able to understand and sign and date the informed consent form approved by the IRB.

Exclusion Criteria:

  • Vulnerable populations: neonates, children, prisoners, institutionalized individuals.
  • Inability or refusal to provide informed consent.
  • History of ocular surgery (except refractive surgery or cataract surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1.BMT Patients (Study)
Patients prior to receiving a bone marrow transplant will be recruited during their initial intake prior to their BM transplant through the PI's regularly scheduled appointment with these patients.
Diagnostic test: The standard care exam and biological specimens' collection
During each visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments or impression cytology of conjunctiva, blood or serum) will be collected.
2.Controls
Patients with no history of eye disease or cancer history
Diagnostic test: The standard care exam and biological specimens' collection
During each visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments or impression cytology of conjunctiva, blood or serum) will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Risk factors and markers for developing eye diseases
Time Frame: Up to 4 years
Number of patients with the risks and markers who have developed the eye diseases during the study
Up to 4 years
2. The mechanisms of eye damage
Time Frame: Up to 4 years
Number of patients who have eye damage during the study
Up to 4 years
The drug acting targets
Time Frame: Up to 4 years
Number of patients who have eye diseases with eye surface changes after the treatment during the study.
Up to 4 years
The effect of ocular Graft-vs-Host Disease on the eye
Time Frame: Up to 4 years
Number of patients who have eye surface changes with Graft-vs-Host Disease during the study
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Sarah Sunshine, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2177GCCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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