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Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes (Lymphoscreen)

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ClinicalTrials.gov Identifier: NCT01042301
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE January 4, 2010
First Posted Date  ICMJE January 5, 2010
Last Update Posted Date September 9, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012) [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
Change History Complete list of historical versions of study NCT01042301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014). [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Official Title  ICMJE Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Brief Summary The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Other: Blood samplings
Study Arms  ICMJE
  • Experimental: Long-term type 1 diabetic patients
    Long-term type 1 diabetic patients
    Intervention: Other: Blood samplings
  • Active Comparator: control patients
    control patients
    Intervention: Other: Blood samplings
  • Experimental: diabetic and transplanted patients
    diabetic and transplanted patients
    Intervention: Other: Blood samplings
  • Experimental: subjects with high risk for diabetes
    subjects with high risk for diabetes
    Intervention: Other: Blood samplings
  • Experimental: patients with recent type 1 diabetes
    patients with recent type 1 diabetes
    Intervention: Other: Blood samplings
  • Experimental: patients with Latent Autoimmune Diabetes
    patients with Latent Autoimmune Diabetes
    Intervention: Other: Blood samplings
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2012)
120
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • at least, 50 patients with "recent" type 1 diabetes,
  • 30 patients with long-term type 1 diabetes,
  • 10 patients with Latent Autoimmune Diabetes,
  • 10 subjects with a risk for diabetes,
  • 20 type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
  • 50 healthy subjects paired to HLA class I and to the age

Those subjects have to respect the following criteria :

  • Age from 7 to 70 -Caucasian
  • Affiliated to a national insurance scheme
  • Written informed consent obtained For children, written informed consent is required from the two parents.

Non-inclusion criteria :

  • Age strictly inferior to 7 or strictly superior to 70 years old
  • Pregnancy
  • Secondary diabetes
  • No written informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01042301
Other Study ID Numbers  ICMJE BRD07/5-A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lucy Chaillous CHU de Nantes
PRS Account Nantes University Hospital
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP