Clinical trial NCT04946721: 2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD
Official title: 2177GCCC: Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease (oGVHD) a Biobank Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Disease
oGVHD
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of patients will be invited to participate in the study.

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.
2. Controls - patients with no history of eye disease or cancer history.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 1. Risk factors and markers for developing eye diseases
timeFrame: Up to 4 years
measure: 2. The mechanisms of eye damage
timeFrame: Up to 4 years
measure: The drug acting targets
timeFrame: Up to 4 years
measure: The effect of ocular Graft-vs-Host Disease on the eye
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Geenebaum Cancer Center, University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Sarah Sunshine, MD
role: PRINCIPAL_INVESTIGATOR
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