NCT01042301

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

7.1 years

First QC Date

January 4, 2010

Last Update Submit

September 7, 2015

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)

    3 years

Secondary Outcomes (1)

  • Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).

    3 years

Study Arms (6)

Long-term type 1 diabetic patients

EXPERIMENTAL

Long-term type 1 diabetic patients

Other: Blood samplings

control patients

ACTIVE COMPARATOR

control patients

Other: Blood samplings

diabetic and transplanted patients

EXPERIMENTAL

diabetic and transplanted patients

Other: Blood samplings

subjects with high risk for diabetes

EXPERIMENTAL

subjects with high risk for diabetes

Other: Blood samplings

patients with recent type 1 diabetes

EXPERIMENTAL

patients with recent type 1 diabetes

Other: Blood samplings

patients with Latent Autoimmune Diabetes

EXPERIMENTAL

patients with Latent Autoimmune Diabetes

Other: Blood samplings

Interventions

Blood samplingsOTHER
Long-term type 1 diabetic patientscontrol patientsdiabetic and transplanted patientspatients with Latent Autoimmune Diabetespatients with recent type 1 diabetessubjects with high risk for diabetes

Eligibility Criteria

Age7 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • at least, 50 patients with "recent" type 1 diabetes,
  • patients with long-term type 1 diabetes,
  • patients with Latent Autoimmune Diabetes,
  • subjects with a risk for diabetes,
  • type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
  • 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.
  • Age strictly inferior to 7 or strictly superior to 70 years old
  • Pregnancy
  • Secondary diabetes
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisParacentesisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Lucy Chaillous

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

September 1, 2007

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

FR(1)