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CompletedNCT05663333DOCTAUpdated Aug 22, 2024

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)

An observational study in Giant Cell Arteritis and Tomography, Optical Coherence, sponsored by Centre Hospitalier William Morey - Chalon sur Saône. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Centre Hospitalier William Morey - Chalon sur Saône · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
14
Ages
50 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Giant Cell Arteritis
  • Tomography, Optical Coherence

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Keywords

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

Giant Cell Arteritis

147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.

This study's enrollment of 14 is below the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.

Browse Giant Cell Arteritis studies →

Lead sponsor

Centre Hospitalier William Morey - Chalon sur Saône is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherDynamic 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

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What researchers measure

Primary outcomes

  1. Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography

    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

    Time frame: Outcome measure is assessed 15 days following temporal artery biopsy

Secondary outcomes

  1. Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography

    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

    Time frame: Outcome measure is assessed 15 days following temporal artery biopsy

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Study locations

1 site
  • Centre Hospitalier William Morey - Chalon sur Saône
    Chalon sur Saône, Saône-et-Loire 71100, France
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References and documents

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. PubMed 34235884 ↗
  • 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. Erratum In: PLoS One. 2023 Dec 19;18(12):e0296315. doi: 10.1371/journal.pone.0296315. PubMed 32866179 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05663333
Lead sponsor
Centre Hospitalier William Morey - Chalon sur Saône
Collaborators
Centre Hospitalier de Mâcon
Responsible party
Thomas Maldiney (Doctor, Centre Hospitalier William Morey - Chalon sur Saône) — Principal investigator
First posted
Dec 23, 2022
Start date
Jan 26, 2023
Primary completion
Jun 30, 2024
Completion
Jul 31, 2024
Last update
Aug 22, 2024

Study contacts

Thomas Maldiney
principal investigator · Centre Hospitalier William Morey - Chalon sur Saône

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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