Genetics and Epigenetics of Graves' Orbitopathy
GeneGO
1 other identifier
observational
12
1 country
1
Brief Summary
Graves' orbitopathy (GO) is an autoimmune disease persisting when immunosuppression is achieved. Orbital fibroblasts from GO patients display peculiar phenotypes even if not exposed to autoimmunity, possibly reflecting genetic or epigenetic mechanisms, to be investigated here. Primary cultures of orbital fibroblasts from GO and control patients will be established. Cell proliferation, release of hyaluronic acid (HA) and HA synthases (HAS) will be measured. Next Generation Sequencing and gene expression analysis of the whole genome will be performed, as well as global DNA methylation assay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedFirst Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedJuly 28, 2020
July 1, 2020
3 months
July 17, 2020
July 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Gene expression
Gene expression in patients vs controls
Baseline
Study Arms (2)
Graves' Orbitopathy
Graves' Orbitopathy patients who undergoing orbital decompressive surgery
Control Patients
Patients undergoing eye surgery for unrelated reasons
Interventions
Not applicable to these subjects. There is no study-related intervention
Eligibility Criteria
Patients with Graves' orbitopathy undergoing decompressione surgery
You may qualify if:
- Diagnosis of Graves' Orbitopathy
- Informed consent
You may not qualify if:
- Lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Cisanello-Endocrinology I and II
Pisa, 56124, Italy
Related Publications (1)
Rotondo Dottore G, Bucci I, Lanzolla G, Dallan I, Sframeli A, Torregrossa L, Casini G, Basolo F, Figus M, Nardi M, Marcocci C, Marino M. Genetic Profiling of Orbital Fibroblasts from Patients with Graves' Orbitopathy. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2176-e2190. doi: 10.1210/clinem/dgab035.
PMID: 33484567DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 28, 2020
Study Start
January 1, 2020
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
July 28, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share