Describe the Progression of Inflammatory Orbitopathy and the Biological Progression of Patients Receiving Second-line Treatment
NCT ID: NCT07117981
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-11-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients followed in endocrinology with the goal of achieving euthyroidism;
* Corticosteroid-resistant patients: patients who have received at least 3 weeks of treatment with 500 mg weekly corticosteroid boluses and have not shown improvement in the clinical activity score (CAS);
* Corticosteroid-dependent patients: relapse with a CAS of 3 or higher when decreasing or stopping corticosteroid therapy;
* Patients with a CAS ≥ 3 or CAS \<3 with moderate to severe orbitopathy (according to EUGOGO);
* Patients treated with immunotherapy, biotherapy, or radiotherapy as second-line treatment;
* Patients who are not opposed to the reuse of their health data.
Exclusion Criteria
* Patients with severe corneal involvement (Grade B or C; NO SPECS classification);
* Patients with optic neuropathy (Grade B and C; NO SPECS classification);
* Patients who have received 1 gram corticosteroid boluses for dysthyroid orbitopathy;
* Patients who have opposed the reuse of their health data.
18 Years
ALL
No
Sponsors
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
OTHER
Responsible Party
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Locations
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, paris, France
CHU Caen Normandie COTE DE NACRE
Caen, , France
CHU Lyon - Hospices Civils de Lyon
Lyon, , France
Hopital Saint Joseph
Marseille, , France
CHU de Montpellier
Montpellier, , France
CHU Nîmes
Nîmes, , France
Hopital Fondation de Rothschild
Paris, , France
CHU de Pontchaillou
Rennes, , France
Hopital Civil / Nouvel Hopital Civil
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Boris BIENVENU, DR
Role: primary
References
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Chin YH, Ng CH, Lee MH, Koh JWH, Kiew J, Yang SP, Sundar G, Khoo CM. Prevalence of thyroid eye disease in Graves' disease: A meta-analysis and systematic review. Clin Endocrinol (Oxf). 2020 Oct;93(4):363-374. doi: 10.1111/cen.14296. Epub 2020 Aug 10.
Bartalena L, Baldeschi L, Dickinson A, Eckstein A, Kendall-Taylor P, Marcocci C, Mourits M, Perros P, Boboridis K, Boschi A, Curro N, Daumerie C, Kahaly GJ, Krassas GE, Lane CM, Lazarus JH, Marino M, Nardi M, Neoh C, Orgiazzi J, Pearce S, Pinchera A, Pitz S, Salvi M, Sivelli P, Stahl M, von Arx G, Wiersinga WM; European Group on Graves' Orbitopathy (EUGOGO). Consensus statement of the European Group on Graves' orbitopathy (EUGOGO) on management of GO. Eur J Endocrinol. 2008 Mar;158(3):273-85. doi: 10.1530/EJE-07-0666. No abstract available.
Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479.
Vargas-Uricoechea H. Autoimmune Thyroid Disease and Differentiated Thyroid Carcinoma: A Review of the Mechanisms That Explain an Intriguing and Exciting Relationship. World J Oncol. 2024 Feb;15(1):14-27. doi: 10.14740/wjon1728. Epub 2023 Dec 9.
Lee JY, Lee MK, Lee JH, Kim K, Bae K, Sohn SY. Cancer Risks of Patients with Graves' Disease Who Received Antithyroid Drugs as Initial Treatment: A Nationwide Population-Based Analysis. Thyroid. 2024 Oct;34(10):1271-1279. doi: 10.1089/thy.2024.0178. Epub 2024 Sep 23.
Goodman RS, Johnson DB, Balko JM. Corticosteroids and Cancer Immunotherapy. Clin Cancer Res. 2023 Jul 14;29(14):2580-2587. doi: 10.1158/1078-0432.CCR-22-3181.
Prummel MF, Bakker A, Wiersinga WM, Baldeschi L, Mourits MP, Kendall-Taylor P, Perros P, Neoh C, Dickinson AJ, Lazarus JH, Lane CM, Heufelder AE, Kahaly GJ, Pitz S, Orgiazzi J, Hullo A, Pinchera A, Marcocci C, Sartini MS, Rocchi R, Nardi M, Krassas GE, Halkias A. Multi-center study on the characteristics and treatment strategies of patients with Graves' orbitopathy: the first European Group on Graves' Orbitopathy experience. Eur J Endocrinol. 2003 May;148(5):491-5. doi: 10.1530/eje.0.1480491.
Other Identifiers
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P23-05
Identifier Type: -
Identifier Source: org_study_id
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