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

Study Overview
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Brief Summary
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Evaluate and study the immunologic changes to the ocular surface in cancer patients.

Detailed Description
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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.

Official Title
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2177GCCC: Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease (oGVHD) a Biobank Study

Conditions
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Dry Eye Disease, oGVHD

Intervention / Treatment
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* Diagnostic Test: The standard care exam and biological specimens' collection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1.BMT Patients (Study)<br>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. | Diagnostic Test: The standard care exam and biological specimens' collection<br>* During each 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.<br>|
| 2.Controls<br>Patients with no history of eye disease or cancer history | Diagnostic Test: The standard care exam and biological specimens' collection<br>* During each 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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