2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
Evaluate and study the immunologic changes to the ocular surface in cancer patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Vulnerable populations: neonates, children, prisoners, institutionalized individuals.
Inability or refusal to provide informed consent.
History of ocular surgery (except refractive surgery or cataract surgery)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
The standard care exam and biological specimens' collection
Diagnostic testDuring 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: 1.BMT Patients (Study)1 intervention
Group B: 2.Controls1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 4 years2
2. The mechanisms of eye damage
Number of patients who have eye damage during the study
Time frame
Up to 4 years3
The drug acting targets
Number of patients who have eye diseases with eye surface changes after the treatment during the study.
Time frame
Up to 4 years4
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
Time frame
Up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov