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NCT Number: NCT04946721

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

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

Recruiting

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases oGVHD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geenebaum Cancer Center, University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Patricia Lesho

CONTACT

[email protected]

410-328-2577

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

The standard care exam and biological specimens' collection

Diagnostic Test

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.

Primary outcomes

  1. 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. 2. The mechanisms of eye damage

    Time frame: Up to 4 years

    Number of patients who have eye damage during the study

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Lesho

CONTACT

[email protected]

410-328-2577

Sarah B Sunshine, MD

CONTACT

[email protected]

667-214-1292

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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