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Trial record 15 of 130 for:    GCA

Study of Circulating Microparticles in Giant Cell Arteritis (MicroGiant)

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ClinicalTrials.gov Identifier: NCT02333708
Recruitment Status : Unknown
Verified September 2016 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date January 5, 2015
First Posted Date January 7, 2015
Last Update Posted Date July 17, 2018
Study Start Date September 2015
Estimated Primary Completion Date September 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02333708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Circulating Microparticles in Giant Cell Arteritis
Official Title Study of Circulating Microparticles in Giant Cell Arteritis
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary and secondary care hospital
Condition
  • Giant Cell Arteritis
  • Acute Phase
Intervention Other: Blood sample
Study Groups/Cohorts
  • GCA group
    Intervention: Other: Blood sample
  • Inflammatory syndrome (without GCA) group
    Intervention: Other: Blood sample
  • Without inflammatory syndrome and without GCA group
    Intervention: Other: Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 6, 2015)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2018
Estimated Primary Completion Date September 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

For GCA group:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02333708
Other Study ID Numbers 2013-A00273-44
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Caen
Study Sponsor University Hospital, Caen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Caen
Verification Date September 2016