NCT02514109

Brief Summary

The diagnosis of sensory neuronopathy is difficult to establish because the only certainty criterion is based on the detection of specific lesions in the posterior spinal ganglion which is usually not possible. There is to date no clinical and electrophysiological criteria or validated biomarker for the diagnosis of this type of neuropathy. In a retrospective study, we analyzed the files of patients with peripheral sensory neuronopathy certain and established clinical and electrophysiological diagnostic criteria for sensitive neuronopathy. We therefore wish now validate these criteria and investigate possible associated antibodies on a prospective cohort of patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
terminated

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

May 1, 2010

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

6.3 years

First QC Date

July 31, 2015

Last Update Submit

September 19, 2016

Conditions

Neuronopathy

Keywords

neuronopathyantibodiesClinical and biological diagnostic criteria

Outcome Measures

Primary Outcomes (1)

  • Likelihood ratio diagnostic criteria established on the study population

    The set of diagnostic criteria giving the best sensitivity and specificity for a diagnosis of sensory neuronopathy (composite measure)

    baseline

Secondary Outcomes (1)

  • Identified antibodies

    baseline

Study Arms (2)

patient

Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuronopathy.

Other: Neurological assessment and Blood sample

control

Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuropathy excluding a neuronopathy.

Other: Neurological assessment and Blood sample

Interventions

Neurological assessment and Blood sampleOTHER

Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS)) and 2 blood collection tubes for antibody screening

controlpatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient group : patient with sensitive neuronopathy Control group :patient without sensitive neuronopathy

You may qualify if:

  • A :Patients Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuronopathy.
  • B :Controls Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuropathy excluding a neuronopathy.

You may not qualify if:

  • Patient with a sensory-motor neuropathy or incomplete clinical evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU Angers

Angers, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Grenoble

Grenoble, 38000, France

Location

Hospices Civils de Lyon

Lyon, 69000, France

Location

AP-HM

Marseille, 13000, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nimes

Nîmes, 30000, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

CHU Poitiers

Poitiers, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Chu Strasbourg

Strasbourg, 67000, France

Location

Chu de Tours

Tours, 37000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for antibodies measure

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Christophe ANTOINE, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 3, 2015

Study Start

May 1, 2010

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

FR(12)