2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The standard care exam and biological specimens' collection.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease, oGVHD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Diagnostic test The standard care exam and biological specimens' collection
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 outcome measures
- 1. Risk factors and markers for developing eye diseases [Time frame: Up to 4 years]
- 2. The mechanisms of eye damage [Time frame: Up to 4 years]
- The drug acting targets [Time frame: Up to 4 years]
- The effect of ocular Graft-vs-Host Disease on the eye [Time frame: Up to 4 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Geenebaum Cancer Center, University of Maryland Medical Center — Baltimore
Publications
- Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. PMID 28736335
- Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20. PMID 28736340
- Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430. PMID 23169882
- McDermott AM. New insight into dry eye inflammation. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8264. doi: 10.1167/iovs.12-11386. No abstract available. PMID 23248237
- Brinkmann V, Reichard U, Goosmann C, Fauler B, Uhlemann Y, Weiss DS, Weinrauch Y, Zychlinsky A. Neutrophil extracellular traps kill bacteria. Science. 2004 Mar 5;303(5663):1532-5. doi: 10.1126/science.1092385. PMID 15001782
- Cooper PR, Palmer LJ, Chapple IL. Neutrophil extracellular traps as a new paradigm in innate immunity: friend or foe? Periodontol 2000. 2013 Oct;63(1):165-97. doi: 10.1111/prd.12025. PMID 23931060
- Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844. PMID 24255046
- Ogawa Y, Okamoto S, Wakui M, Watanabe R, Yamada M, Yoshino M, Ono M, Yang HY, Mashima Y, Oguchi Y, Ikeda Y, Tsubota K. Dry eye after haematopoietic stem cell transplantation. Br J Ophthalmol. 1999 Oct;83(10):1125-30. doi: 10.1136/bjo.83.10.1125. PMID 10502571
Identifiers
NCT: NCT04946721 · 2177GCCC