Biomarkers in Giant Cells Arteritis (BioACG)
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|ClinicalTrials.gov Identifier: NCT02844023|
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.
Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.
So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.
With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.
The main goal is to determine a new diagnosis marker for giant cells arteritis.
|Condition or disease||Intervention/treatment||Phase|
|Giant Cells Arteritis||Behavioral: Clinical evaluation Other: Paraclinical evaluation Device: Imaging Other: Ophthalmologic examination Biological: Dosage of biomarkers||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers in Giant Cells Arteritis|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Patient with giant gells arteritis
50 patients with giant gells arteritis
Behavioral: Clinical evaluation
Other: Paraclinical evaluation
Symptom inflammatory, biomarkers.
Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.
Other: Ophthalmologic examination
50 control patients : blood from French national blood service (EFS)
Biological: Dosage of biomarkers
- Biomarkers's serum sampling [ Time Frame: 3 minutes ]For dosage of biomarkers in serum, like serum amyloid A or interleukins.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844023
|Contact: Laurence LB Bouillet, Professor||04 76 76 55 firstname.lastname@example.org|
|Contact: Anais Dartevel||06 27 27 30 email@example.com|
|La Tronche, France, 38700|
|Contact: Laurence Bouillet, Professor 04 76 76 53 13 firstname.lastname@example.org|
|Contact: Anais Dartevel 06 27 27 30 46 email@example.com|
|Principal Investigator:||Laurence Bouillet, Professor||Grenoble Hospital University|