Horton's DiseaseNCT02065297
Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
An observational study of Horton's Disease and Infectious Disease, run by Centre Hospitalier Universitaire Dijon at 3 sites in France.
Trial summary
The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Horton's Disease, Infectious Disease, Neoplasia
- What is being tested?
- 1 blood sample and 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)
- How many people
- 143 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Jul 2009to 7 Jan 2016
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Horton' s disease Patients with an infectious disease Patients with neoplasia ( solid tumor or hemopathy ) Healthy controls
Who may be able to join
- Patients
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Age: 50 to 90 years
- Patients with Horton' s disease :
- at the diagnosis, before any treatment
Show all 24Show fewer
- or in remission
- or in relapse
- Patients with an infectious disease :
- Bacteriologically or radiologically confirmed
- Presenting an inflammatory syndrome defined by :
- CRP ≥ 10 mg / L
- and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1
- Patients with neoplasia ( solid tumour or hemopathy ) :
- At the diagnosis, before treatment by chemotherapy
- Presenting an inflammatory syndrome defined by:
- CRP ≥ 10 mg / L
- and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1
- Controls :
- These are healthy volunteers recruited among blood donators at Dijon CHU, voluntary hospital personnel ( nurses, doctors and secretaries ), patients at the EPHAD ( Champmaillot centre for geriatric patients ) and patients without infectious, inflammatory, or auto-immune disease ( CRP < 5mg / L ) or cancer recruited from the investigating departments of Dijon CHU. They will be matched for age and sex.
- Age: 18 - 90 years
- Patients with national health insurance cover
- who have provided written informed consent
- Absence of an inflammatory syndrome ( CRP < 5 mg / L )
Who cannot join
- Any patient who does not meet the inclusion criteria
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de BESANCON
Besançon, 25000
CHU de DIJON
Dijon, 21079
CH de METZ
Metz, 57000
About this study
The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease.
Participation consists in taking one or several blood samples depending on the group patients/controls.
- Conditions
- Horton's Disease, Infectious Disease, Neoplasia, Solid Tumor, Hemopathy
- Being tested
- 1 blood sample, 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)
- Medical subject headings
- Giant Cell Arteritis, Communicable Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 blood sampleOther
2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)Other
| Study group | Role | What they receive |
|---|---|---|
| Horton's disease | Not described Receives: Other: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse) | |
| Infectious disease | Not described Receives: Other: 1 blood sample | |
| Neoplasia | Not described Receives: Other: 1 blood sample | |
| Control | Not described Receives: Other: 1 blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum
Measured: Up to 6 months
Quantification of LTh17 by flow cytometry
Measured: Up to 6 months
Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA
Measured: Up to 6 months
Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start28 Jul 2009
- Primary completion7 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horton's DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065297
- Sponsor's protocol ID
- AUDIA-SAMSON HORTON TH17
- Status last verified
- May 2019
- First submitted
- 13 Feb 2014
- Last updated
- 6 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)
- ClinicalTrials.gov ID
- NCT02065297
- Acronym / sponsor ID
- AUDIA-SAMSON HORTON TH17
- Conditions
- Horton's Disease, Infectious Disease, Neoplasia, Solid Tumor, Hemopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 28 Jul 2009 (actual)
- Primary completion
- 7 Jan 2016 (actual)
- First posted
- 19 Feb 2014 (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.
The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease.
Participation consists in taking one or several blood samples depending on the group patients/controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Horton's disease | – | Other: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse) |
| Infectious disease | – | Other: 1 blood sample |
| Neoplasia | – | Other: 1 blood sample |
| Control | – | Other: 1 blood sample |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Horton' s disease Patients with an infectious disease Patients with neoplasia ( solid tumor or hemopathy ) Healthy controls
Key inclusion criteria (24 listed)
- Patients
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Age: 50 to 90 years
- at the diagnosis, before any treatment
Key exclusion criteria (1 listed)
- Any patient who does not meet the inclusion criteria
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 |
|---|---|---|
| 1 blood sample | Other | Control, Infectious disease, Neoplasia |
| 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse) | Other | Horton's disease |
Primary outcome
Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum
Time frame: Up to 6 months
Quantification of LTh17 by flow cytometry
Time frame: Up to 6 months
Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA
Time frame: Up to 6 months
Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations
Time frame: Up to 6 months
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 6 May 2019.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Horton's Disease and Infectious Disease, run by Centre Hospitalier Universitaire Dijon at 3 sites 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 24 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 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum (time frame: Up to 6 months). The study lists 4 primary outcomes in all. 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 6 May 2019.