2177GCCC: Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease (oGVHD) a Biobank Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 1. Risk factors and markers for developing eye diseases
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: The standard care exam and biological specimens' collection (Diagnostic Test)
2.Controls
Patients with no history of eye disease or cancer history
Intervention: The standard care exam and biological specimens' collection (Diagnostic Test)
Outcomes
Primary Outcomes
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
2. The mechanisms of eye damage
Time Frame: Up to 4 years
Number of patients who have eye damage during the study
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.
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
Secondary Outcomes
No secondary outcomes reported