NCT02862301

Brief Summary

The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and healthy controls (control group).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

4.2 years

First QC Date

August 3, 2016

Last Update Submit

November 15, 2019

Conditions

Demyelinating Autoimmune Diseases, CNS

Keywords

Histone DeacetylasesHistone Acetyltransferases

Outcome Measures

Primary Outcomes (1)

  • HDAC/ HAT enzymatic activity (ratio)

    day of inclusion

Study Arms (2)

Control group

OTHER

Healthy volunteers, free of any inflammatory disease. A blood sample is performed on the day of inclusion.

Biological: blood sample

CIS group

EXPERIMENTAL

patients with Clinically isolated syndrome. A blood sample is performed on the day of inclusion and after 3 months.

Biological: blood sample

Interventions

blood sampleBIOLOGICAL
CIS groupControl group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically isolated syndrome within the last 6 weeks (CIS group)
  • Healthy volunteer, free of any inflammatory disease (control group)
  • Patient able to understand the reason of the study
  • Signed informed consent

You may not qualify if:

  • Pregnancy
  • Systemic corticosteroid therapy (\>1mg/kg)
  • Immunosuppressive/immunomodulatory therapy (prior or ongoing) (CIS group)
  • Patient with ongoing infection (Control group)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Besançon, France

RECRUITING

MeSH Terms

Conditions

Demyelinating Autoimmune Diseases, CNS

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous SystemNervous System DiseasesLeukoencephalopathiesBrain DiseasesCentral Nervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Matthieu Béreau, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu Béreau, MD

CONTACT

mbereau@chu-besancon.fr

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

August 3, 2016

First Posted

August 11, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)