Giant Cell ArteritisMicroGiantNCT02333708
Study of Circulating Microparticles in Giant Cell Arteritis
An observational study of Giant Cell Arteritis and Acute Phase, run by University Hospital, Caen at 1 site in France.
Trial summary
To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Giant Cell Arteritis, Acute Phase
- What is being tested?
- Blood sample
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary and secondary care hospital
Who may be able to join
- Men and women ≥ 18 years of age Patient affiliated to social security regimen
- Informed and having signed the consent form to take part in the study.
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome and having
- Either temporal artery biopsy showing characteristic GCA abnormality
- Or inflammatory arteritis on imaging examination
Who cannot join
- Persons under protection of the court or guardianship
- Inability to understand or to follow study procedures
- Dementia
- cancer diagnosed within the previous 5 years (except for non-melanoma skin cancer or in situ carcinoma of the cervix)non-contributory or inconclusive temporal artery biopsy
- Any conditions that might interfere with MPs level: diabetes, recent endo-arterial gesture, current treatment with corticosteroids.
- Participation in another ongoing clinical trial Current anticoagulant therapy
- Active infectious disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Côte de Nacre
Caen, 14000
Boris BIENVENU, +33231064579
About this study
To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.
- Conditions
- Giant Cell Arteritis, Acute Phase
- Being tested
- Blood sample
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| GCA group | Not described Receives: Other: Blood sample | |
| Inflammatory syndrome (without GCA) group | Not described Receives: Other: Blood sample | |
| Without inflammatory syndrome and without GCA group | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of microparticles in the blood of patients with histologically proven giant cell arteritis.
Level of microparticles (MPs) in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startSep 2015
- Primary completion16 Sep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333708
- Sponsor's protocol ID
- 2013-A00273-44
- Acronym
- MicroGiant
- Status last verified
- Sep 2016
- First submitted
- 5 Jan 2015
- Last updated
- 9 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating Microparticles in Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT02333708
- Acronym / sponsor ID
- MicroGiant / 2013-A00273-44
- Conditions
- Giant Cell Arteritis, Acute Phase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 16 Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- 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.
To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GCA group | – | Other: Blood sample |
| Inflammatory syndrome (without GCA) group | – | Other: Blood sample |
| Without inflammatory syndrome and without GCA group | – | Other: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary and secondary care hospital
Key inclusion criteria (5 listed)
- Men and women ≥ 18 years of age Patient affiliated to social security regimen
- Informed and having signed the consent form to take part in the study.
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome and having
Key exclusion criteria (7 listed)
- Persons under protection of the court or guardianship
- Inability to understand or to follow study procedures
- Dementia
- cancer diagnosed within the previous 5 years (except for non-melanoma skin cancer or in situ carcinoma of the cervix)non-contributory or inconclusive temporal artery biopsy
- Any conditions that might interfere with MPs level: diabetes, recent endo-arterial gesture, current treatment with corticosteroids.
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 |
|---|---|---|
| Blood sample | Other | GCA group, Inflammatory syndrome (without GCA) group, Without inflammatory syndrome and without GCA group |
Primary outcome
Level of microparticles in the blood of patients with histologically proven giant cell arteritis.
Time frame: Baseline
Level of microparticles (MPs) in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
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 Acute Phase, run by University Hospital, Caen 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris BIENVENU, MD, PhD, (+33231064579, bienvenu-b@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of microparticles in the blood of patients with histologically proven giant cell arteritis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2022.