Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population (CONTROL)

October 19, 2020 updated by: GeNeuro Innovation SAS

A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood

This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

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

      • Annemasse, France, 74100
        • Etablissement Français du Sang Rhône Alpes - 1 route de Taninges

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Blood donors coming for regular blood draw in the center of transfusion.

Description

Inclusion Criteria:

  • Signature of an informed consent;
  • Male or female between 18 and 60 years of age.

Exclusion Criteria:

  • Positive serology for hepatitis B or C or HIV;
  • Acute infection at inclusion;
  • Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease;
  • Pregnancy or breastfeeding;
  • Heavy smokers i.e. more than 10 cigarettes per day;
  • History of alcohol or drug abuse in the last 3 years;
  • Participation in a clinical trial (within the last 3 months).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
25 healthy volunteers
No study treatments administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a control value for the levels of MSRV expression in the normal population over time
Time Frame: 1 year

Establish a control value for the levels of MSRV expression in the normal population over time using 3 approaches:

  • MSRV transcripts in PBMC;
  • MSRV transcripts in plasma;
  • MSRV-Env protein in serum.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory markers and reverse transcriptase activity in blood.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

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

October 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

February 1, 2018

More Information

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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