Ocular Complications From Cancer Therapy - Patient Registry and Biobank
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
The purpose of this study is to collect data on patients seen at University of Maryland after undergoing cancer therapy. Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. Potential subjects will be enrolled from the clinical practice of the investigator at the time of their eye examination visit. A standard of care exam will be performed pertinent to the reason for the visit. In addition to the standard of care exam, certain biological specimens (ocular surface wash, mucocellular material, corneal filaments, impression cytology, and/or blood) will be collected, stored, and analyzed to obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patients (greater than 18 years of age)
Deny a history of eye diseases (excluding cataract, glaucoma, mild dry eye disease, or history of cataract or refractive surgery)
Patients who have a history of allogenic HSCT with all stem cell sources including bone marrow, PBSC, cord AND/OR patients with a history of prior cancer therapy including BMT, chemotherapy, and immunotherapy
Patients will be recruited after their HSCT or cancer therapy at their ophthalmology appointment
Disqualifiers
Vulnerable populations: neonates, children, prisoners, institutionalized individuals
Inability or refusal to provide informed consent.
History of ocular surgery or ocular disease (except refractive or cataract surgery, mild dry eye disease, or glaucoma).
Vulnerable populations: neonates, children, prisoners, institutionalized individuals
Trial population
Patients who have undergone cancer treatment and in control patients who have not undergone either cancer therapy. The goal of the control patients is to have a direct comparison of 'normal' tear samples as compared to tear/ocular samples from those patients who have undergone cancer treatment.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Eye exam
Procedure/SurgeryPrevious medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. A standard of care exam will be performed to the reason for the visit. In addition to the standard of care exam, those in the Cancer Therapy arm will have certain biological samples (tear collection, impression cytology, and/or blood) collected, stored, and analyzed so we may obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Cancer Therapy1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
International Chronic Ocular Graft Versus Host Disease Severity Score
The International Chronic oGVHD severity score (Ogawa, Y. et al. International Chronic Ocular Graft-vs-Host-Disease (GVHD) Consensus Group: Proposed Diagnostic Criteria for Chronic GVHD (Part I). Sci Rep 3, 3419 (2013). https://doi.org/10.1038/srep03419) is the standard of care for diagnosing and monitoring ocular GvHD. Briefly, this is calculated based on the sum of the patient's Schirmer's severity score (range of 0-3), OSDI severity score (range of 0-3), corneal fluorescein staining severity score (range of 0-3), and conjunctival injection severity score (range of 0-2). This sum ranges from 0 to 11. To diagnose whether a patient has no oGVHD, probable oGVHD, or definite oGVHD, there are two separate scales depending on whether the patient has systemic GVHD or not. Based on the sum of the characteristics, one can diagnose whether or not the patient has oGVHD. Patients are categorized into None, Probable or Definite and the criteria is different based on their systemic GvHD status.
Time frame
At the time of intervention (eye exam), between on average 3 months to 5 years post-transplant, but this can also extend up to 10 years post-transplant. The expected average will be 3 years post-transplant.Sponsors and contacts
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Source ClinicalTrials.gov