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

September 7, 2015 updated by: Nantes University Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-term type 1 diabetic patients
Other: Blood samplings
Active Comparator: control patients
Other: Blood samplings
Experimental: diabetic and transplanted patients
Other: Blood samplings
Experimental: subjects with high risk for diabetes
Other: Blood samplings
Experimental: patients with recent type 1 diabetes
Other: Blood samplings
Experimental: patients with Latent Autoimmune Diabetes
Other: Blood samplings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Lucy Chaillous, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD07/5-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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