NCT04554290

Brief Summary

Temporal artery biopsy is a useful tool helping to the diagnosis of giant cell arteritis. However, other diagnoses might be associated with abnormal temporal artery biopsy. The purpose of this study is to describe the frequency of giant cell arteritis differential diagnoses with positive temporal artery biopsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

September 14, 2020

Last Update Submit

October 23, 2023

Conditions

Giant Cell ArteritisVasculitis

Keywords

giant cell arteritistemporal artery biopsyvasculitis

Outcome Measures

Primary Outcomes (1)

  • percentage of giant cell arteritis and differential diagnoses

    baseline

Study Arms (1)

positive temporal artery biopsy

all adult patients with significant inflammation shown on temporal artery biopsy

Diagnostic Test: temporal artery biopsy

Interventions

temporal artery biopsyDIAGNOSTIC_TEST

description of temporal artery biopsy features, and its correlation with diagnosis of giant cell arteritis or other differential diagnoses.

positive temporal artery biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with significant inflammation on temporal artery biospy, with a final diagnosis of giant cell arteritis or an other diagnosis.

You may qualify if:

  • positive artery biopsy between january 1st 2000 and july 25th 2019

You may not qualify if:

  • orther vascular biopsy than temporal artery biospy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy University Hospital

Nancy, Lorraine, 54500, France

Location

Related Publications (1)

  • Pontille F, Decker P, Gauchotte G, Jaussaud R, Moulinet T. Diagnoses associated with temporal arteritis. Eur J Intern Med. 2023 Nov;117:140-143. doi: 10.1016/j.ejim.2023.08.010. Epub 2023 Aug 14. No abstract available.

    PMID: 37586985RESULT

MeSH Terms

Conditions

Giant Cell ArteritisVasculitis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

August 1, 2020

Primary Completion

March 30, 2021

Study Completion

December 30, 2022

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

FR(1)