Registry and Biobank of Patients With a History of Cancer Therapy

NCT06874283 RECRUITING

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.

Details

Lead sponsor	University of Maryland, Baltimore
Status	RECRUITING
Enrolment	150
Start date	2025-05-13
Completion	2031-04

Conditions

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

Interventions

• Eye exam

Primary outcomes

• International Chronic Ocular Graft Versus Host Disease Severity Score — 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.

Countries

United States