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

NCT04946721 | Recruiting

• 1 other identifier: 2177GCCC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Disease; oGVHD

Outcome Measures

Primary Outcomes (4)

• 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

  Up to 4 years

• 2. The mechanisms of eye damage

  Number of patients who have eye damage during the study

  Up to 4 years

• The drug acting targets

  Number of patients who have eye diseases with eye surface changes after the treatment during the study.

  Up to 4 years

• 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

  Up to 4 years

Study Arms (2)

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.

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

2.Controls

Patients with no history of eye disease or cancer history

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

Interventions

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.

1.BMT Patients (Study); 2.Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Vulnerable populations: neonates, children, prisoners, institutionalized individuals.
• Inability or refusal to provide informed consent.
• History of ocular surgery (except refractive surgery or cataract surgery)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Geenebaum Cancer Center, University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.

  PMID: 25529383 BACKGROUND

• Inamoto Y, Valdes-Sanz N, Ogawa Y, Alves M, Berchicci L, Galvin J, Greinix H, Hale GA, Horn B, Kelly D, Liu H, Rowley S, Schoemans H, Shah A, Lupo Stanghellini MT, Agrawal V, Ahmed I, Ali A, Bhatt N, Byrne M, Chhabra S, DeFilipp Z, Fahnehjelm K, Farhadfar N, Horn E, Lee C, Nathan S, Penack O, Prasad P, Rotz S, Rovo A, Yared J, Pavletic S, Basak GW, Battiwalla M, Duarte R, Savani BN, Flowers MED, Shaw BE, Petricek I. Ocular graft-versus-host disease after hematopoietic cell transplantation: Expert review from the Late Effects and Quality of Life Working Committee of the CIBMTR and Transplant Complications Working Party of the EBMT. Bone Marrow Transplant. 2019 May;54(5):662-673. doi: 10.1038/s41409-018-0340-0. Epub 2018 Dec 7.

  PMID: 30531954 BACKGROUND

• Abud TB, Amparo F, Saboo US, Di Zazzo A, Dohlman TH, Ciolino JB, Hamrah P, Dana R. A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease. Ophthalmology. 2016 Jul;123(7):1449-57. doi: 10.1016/j.ophtha.2016.02.044. Epub 2016 Apr 13.

  PMID: 27086024 BACKGROUND

• An S, Raju I, Surenkhuu B, Kwon JE, Gulati S, Karaman M, Pradeep A, Sinha S, Mun C, Jain S. Neutrophil extracellular traps (NETs) contribute to pathological changes of ocular graft-vs.-host disease (oGVHD) dry eye: Implications for novel biomarkers and therapeutic strategies. Ocul Surf. 2019 Jul;17(3):589-614. doi: 10.1016/j.jtos.2019.03.010. Epub 2019 Apr 6.

  PMID: 30965123 BACKGROUND

• Lelli GJ Jr, Musch DC, Gupta A, Farjo QA, Nairus TM, Mian SI. Ophthalmic cyclosporine use in ocular GVHD. Cornea. 2006 Jul;25(6):635-8. doi: 10.1097/01.ico.0000208818.47861.1d.

  PMID: 17077652 BACKGROUND

• Kwon J, Surenkhuu B, Raju I, Atassi N, Mun J, Chen YF, Sarwar MA, Rosenblatt M, Pradeep A, An S, Dhall N, Mun C, Jain S. Pathological consequences of anti-citrullinated protein antibodies in tear fluid and therapeutic potential of pooled human immune globulin-eye drops in dry eye disease. Ocul Surf. 2020 Jan;18(1):80-97. doi: 10.1016/j.jtos.2019.10.004. Epub 2019 Oct 10.

  PMID: 31606460 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Certain biological specimens (ocular surface wash, mucocellular material, corneal filaments or impression cytology, or blood) will be collected and stored and analyzed to obtain immunologic, cellular, or molecular mechanistic insights into the patient's disease processes.

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Sarah Sunshine, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah B Sunshine, MD

CONTACT

667-214-1292; ssunshine@som.umaryland.edu

Patricia Lesho

CONTACT

410-328-2577; plesho@umm.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 1, 2021
• Study Start: April 27, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)