Histopathological Analysis of Temporal Artery Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients With Suspected Giant Cell Arteritis (DOCTA) (DOCTA)

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ClinicalTrials.gov Identifier: NCT05663333

Recruitment Status : Recruiting

First Posted : December 23, 2022

Last Update Posted : February 15, 2023

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Centre Hospitalier de Mâcon

Information provided by (Responsible Party):

Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône

Study Description

Brief Summary:

Giant cell arteritis (GCA) is a type of large vessel granulomatous vasculitis responsible for the inflammation of the aorta and the branches of the external carotid, notably temporal arteries. The diagnosis of GCA relies upon the identification of vasculitis following histopathological analysis of temporal artery biopsy (TAB) showing mononuclear cells infiltration, fragmentation of the internal elastic lamina as well as significant intimal hyperplasia. Apart from its lack of sensitivity, one of the weaknesses of TAB is the delay in obtaining the result due to the time required to prepare the sample for histological analysis. Pursuing the idea to improve TAB performances, our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes of GCA. The present work suggests a further use of dynamic FF-OCT on TAB for a direct visualization of the mononuclear cells infiltration to ensure rapid on-site diagnosis of GCA.

Condition or disease	Intervention/treatment
Giant Cell Arteritis Tomography, Optical Coherence	Other: Dynamic full-field optical coherence tomography analysis of temporal artery biopsy

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Histopathological Analysis of Temporal Artery Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients With Suspected Giant Cell Arteritis
Actual Study Start Date :	January 26, 2023
Estimated Primary Completion Date :	June 30, 2024
Estimated Study Completion Date :	July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Giant Cell Arteritis Polymyalgia Rheumatica

Genetic and Rare Diseases Information Center resources: Giant Cell Arteritis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
DOCTA cohort Patients > 50 years of age with suspected giant cell arteritis requiring temporal artery biopsy in the dermatology department	Other: Dynamic full-field optical coherence tomography analysis of temporal artery biopsy Dynamic full-field optical coherence tomography analysis of temporal artery biopsy in the dermatology department before conventional histopathological analysis

Outcome Measures

Primary Outcome Measures :

Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography [ Time Frame: Outcome measure is assessed 15 days following temporal artery biopsy ]
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the normal structures of a temporal artery biopsy, i.e. the tripartite architecture with a clear distinction between intima (endothelial cells), media (vascular smooth muscle cells) and adventitia, both internal and external elastic lamina, and vasa vasorum

Secondary Outcome Measures :

Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography [ Time Frame: Outcome measure is assessed 15 days following temporal artery biopsy ]
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify histopathological features of giant cell arteritis, i.e. infiltration of mononuclear cells in the three layers of the artery, fragmentation of the internal elastic lamina, intimal hyperplasia and neoangiogenesis

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patient > 50 years of age with suspected giant cell arteritis who received temporal artery biopsy

Criteria

Inclusion Criteria:

patient > 50 years of age with suspected giant cell arteritis who received temporal artery biopsy between start study date and primary completion date

Exclusion Criteria:

inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05663333

Contacts

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Contact: Thomas Maldiney	+33 3 85 91 01 11	thomas.maldiney@ch-chalon71.fr
Contact: Thibault Maillet		thmaillet@ch-macon.fr

Locations

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France
Centre Hospitalier William Morey - Chalon sur Saône	Recruiting
Chalon sur Saône, Saône-et-Loire, France, 71100
Contact: Thomas Maldiney +33 3 85 91 01 11 thomas.maldiney@ch-chalon71.fr

Sponsors and Collaborators

Centre Hospitalier William Morey - Chalon sur Saône

Centre Hospitalier de Mâcon

Investigators

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Principal Investigator:	Thomas Maldiney	Centre Hospitalier William Morey - Chalon sur Saône

More Information

Publications:

Maz M, Chung SA, Abril A, Langford CA, Gorelik M, Guyatt G, Archer AM, Conn DL, Full KA, Grayson PC, Ibarra MF, Imundo LF, Kim S, Merkel PA, Rhee RL, Seo P, Stone JH, Sule S, Sundel RP, Vitobaldi OI, Warner A, Byram K, Dua AB, Husainat N, James KE, Kalot MA, Lin YC, Springer JM, Turgunbaev M, Villa-Forte A, Turner AS, Mustafa RA. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Rheumatol. 2021 Aug;73(8):1349-1365. doi: 10.1002/art.41774. Epub 2021 Jul 8.

Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.

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Responsible Party:	Thomas Maldiney, Doctor, Centre Hospitalier William Morey - Chalon sur Saône
ClinicalTrials.gov Identifier:	NCT05663333
Other Study ID Numbers:	DOCTA
First Posted:	December 23, 2022 Key Record Dates
Last Update Posted:	February 15, 2023
Last Verified:	February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône:


Giant Cell Arteritis Temporal Artery Biopsy Full-field Optical Coherence Tomography

Additional relevant MeSH terms:

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Polymyalgia Rheumatica Giant Cell Arteritis Arteritis Vasculitis Vascular Diseases Cardiovascular Diseases Vasculitis, Central Nervous System Autoimmune Diseases of the Nervous System Nervous System Diseases Cerebrovascular Disorders	Brain Diseases Central Nervous System Diseases Skin Diseases, Vascular Skin Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases

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