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

Recruiting

• Conditions: oGVHD; Dry Eye Disease
• Interventions: Diagnostic Test: The standard care exam and biological specimens' collection

• Registration Number: NCT04946721
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-07-01
• Study Start: 2022-04-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1.BMT Patients (Study)	The standard care exam and biological specimens' collection	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	The standard care exam and biological specimens' collection	Patients with no history of eye disease or cancer history

Primary Outcome Measures

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

Trial Locations

Locations (1)

Geenebaum Cancer Center, University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States