Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis (Sclerocadh1)

March 23, 2016 updated by: University Hospital, Grenoble
Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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
      • Grenoble, France, 38043
        • Grenoble University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • group 1: systemic sclerosis
  • group 2: raynaud primary disease

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Systemic sclerosis
patients with systemic sclerosis
Biological: soluble Ve cadherin
dosage of soluble VE cadherine in each arms
Sham Comparator: primary raynaud disease
patients with primary raynaud disease
Biological: soluble Ve cadherin
dosage of soluble VE cadherine in each arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon
Time Frame: At 30 days average

Level of human sVE and antibody VE-cadherin in blood will be determined by ELISA test in both groups Scleroderma and Primary Raynaud's Phenomenon.

The methodology of dosage of sVE is based on the pattern:WO/2008/062314 The methodolody of the dosage of antibody VE-cadherin is based on the pattern WO/2012/136820 .

Group Scleroderma (N=60) versus Primary Raynaud's Phenomenon (N=20). Shapiro test.
At 30 days average

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

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

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00186-41

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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