NCT06874283

Ocular Complications From Cancer Therapy - Patient Registry and Biobank

Registry and Biobank of Patients With a History of Cancer Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Graft Versus Host Disease in Eye
• Ocular Complications
• Inflammatory Dry Eye Disease

Interventions

Type	Name	Description
PROCEDURE	Eye exam	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.

Timeline

• Start date: 2025-05-13
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2025-03-13
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States