Ocular Complications From Cancer Therapy - Patient Registry and Biobank

NCT06874283 | Recruiting DMC

• 1 other identifier: 24105GCCC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ocular graft versus host disease; allogenic stem cell transplant; blood cancer; ocular complications; inflammatory dry eye disease; ocular surface disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

Cancer Therapy

The intervention administered will be the eye exam and research protocols (e.g. tear collection, impression cytology, and blood collection)

Procedure: Eye exam

Control

The intervention administered will be the standard of care procedures of the eye exam.

Procedure: Eye exam

Interventions

Eye exam PROCEDURE

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.

Cancer Therapy; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Stoler Outpatient Cancer Center at the University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Sarah Sunshine, MD

CONTACT

667-214-1292; ssunshine@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 13, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)