- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804660
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
Intervention / Treatment
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
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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:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN-E-003
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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