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)

NCT ID: NCT05663333

Last Updated: 2024-08-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-26

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Giant Cell Arteritis Tomography, Optical Coherence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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DOCTA cohort

Patients \> 50 years of age with suspected giant cell arteritis requiring temporal artery biopsy in the dermatology department

Dynamic full-field optical coherence tomography analysis of temporal artery biopsy

Intervention Type OTHER

Dynamic full-field optical coherence tomography analysis of temporal artery biopsy in the dermatology department before conventional histopathological analysis

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Mâcon

OTHER

Sponsor Role collaborator

Centre Hospitalier William Morey - Chalon sur Saône

OTHER

Sponsor Role lead

Responsible Party

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Thomas Maldiney

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Maldiney

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier William Morey - Chalon sur Saône

Locations

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Centre Hospitalier William Morey - Chalon sur Saône

Chalon-sur-Saône, Saône-et-Loire, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 34235884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32866179 (View on PubMed)

Other Identifiers

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DOCTA

Identifier Type: -

Identifier Source: org_study_id

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