Giant Cell ArteritisNCT04554290
Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy
An observational study of Giant Cell Arteritis and Vasculitis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis, Vasculitis
- What is being tested?
- temporal artery biopsy
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with significant inflammation on temporal artery biospy, with a final diagnosis of giant cell arteritis or an other diagnosis.
Who may be able to join
- positive artery biopsy between january 1st 2000 and july 25th 2019
Who cannot join
- orther vascular biopsy than temporal artery biospy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy: a Monocentric Retrospective Study
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.
- Conditions
- Giant Cell Arteritis, Vasculitis
- Being tested
- temporal artery biopsy
- Keywords
- giant cell arteritis, temporal artery biopsy, vasculitis
- Medical subject headings
- Giant Cell Arteritis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporal artery biopsyDiagnostic test
description of temporal artery biopsy features, and its correlation with diagnosis of giant cell arteritis or other differential diagnoses.
| Study group | Role | What they receive |
|---|---|---|
| positive temporal artery biopsy | all adult patients with significant inflammation shown on temporal artery biopsy Receives: Diagnostic Test: temporal artery biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of giant cell arteritis and differential diagnoses
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Aug 2020
- Primary completion30 Mar 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas MOULINET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554290
- Sponsor's protocol ID
- 2020PI061
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2020
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37586985
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy: a Monocentric Retrospective Study
- ClinicalTrials.gov ID
- NCT04554290
- Acronym / sponsor ID
- 2020PI061
- Conditions
- Giant Cell Arteritis, Vasculitis
- Keywords
- giant cell arteritis, temporal artery biopsy, vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| positive temporal artery biopsy | – | Diagnostic Test: temporal artery biopsyall adult patients with significant inflammation shown on temporal artery biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with significant inflammation on temporal artery biospy, with a final diagnosis of giant cell arteritis or an other diagnosis.
Key inclusion criteria (1 listed)
- positive artery biopsy between january 1st 2000 and july 25th 2019
Key exclusion criteria (1 listed)
- orther vascular biopsy than temporal artery biospy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temporal artery biopsydescription of temporal artery biopsy features, and its correlation with diagnosis of giant cell arteritis or other differential diagnoses. | Diagnostic test | positive temporal artery biopsy |
Primary outcome
percentage of giant cell arteritis and differential diagnoses
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Results publication: PubMed 37586985Pontille 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Vasculitis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of giant cell arteritis and differential diagnoses (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.