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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: oGVHD; Dry Eye Disease

Treatments: Diagnostic Test: The standard care exam and biological specimens' collection

Study type: Observational

Funder types: Other

Identifiers

NCT04946721

2177GCCC

Details and patient eligibility

About

Evaluate and study the immunologic changes to the ocular surface in cancer patients.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

150 participants in 2 patient groups

1.BMT Patients (Study)

Description:

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.

Treatment:

Diagnostic Test: The standard care exam and biological specimens' collection

2.Controls

Description:

Patients with no history of eye disease or cancer history

Treatment:

Diagnostic Test: The standard care exam and biological specimens' collection