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Completed

NCT Number: NCT01804660

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Etablissement Français du Sang Rhône Alpes - 1 route de Taninges

Annemasse, 74100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No study treatments administered

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. Inflammatory markers and reverse transcriptase activity in blood.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GeNeuro Innovation SAS

Industry

Registry information

Official study title

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

Acronym: CONTROL

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2013
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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