RIS International Cohort

May 23, 2022 updated by: Centre Hospitalier Universitaire de Nice

The Radiologically Isolated Syndrome International Cohort

The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.

Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco…), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.

(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects demonstrating white matter T2 lesion suggestive of demyelination, asymptomatic with a normal neurological exam, corresponding to RIS diagnostic criteria.

Description

Inclusion Criteria:

  • white matter T2 lesions suggestive of demyelination
  • asymptomatic
  • normal neurological exam

Exclusion Criteria:

  • abnormal neurological exam,
  • suspicion of another disease explaining MRI lesions.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RIS/1-2 criteria
Other: No intervention
No intervention
RIS/3-4 criteria
Other: No intervention
No intervention
NON RIS/0 criteria
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of lesions T2-weighted sequence at the index scan
Time Frame: at inclusion
number of T2-weighted sequence
at inclusion
Identification of lesions T2-weighted sequence at the index scan
Time Frame: at inclusion
localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)
at inclusion
Identification of lesions T1 sequence with and without Gd at the index scan.
Time Frame: at inclusion
Lesions number
at inclusion
Identification of lesions T1 sequence with and without Gd at the index scan.
Time Frame: at inclusion
localisation of interest
at inclusion
Radiological progression : new T2 lesions
Time Frame: year 1
localisation of interest
year 1
Radiological progression : new contrast enhancing lesions
Time Frame: year 1
Lesions number
year 1
Radiological progression : new contrast enhancing lesions
Time Frame: year 1
localisation of interest
year 1
Brain atrophy
Time Frame: year 1
measurement of global and regional grey matter volume measurement of global and regional white matter volume
year 1
Brain atrophy
Time Frame: year 2
measurement of global and regional grey matter volume measurement of global and regional white matter volume
year 2
Brain atrophy
Time Frame: year 3
measurement of global and regional grey matter volume measurement of global and regional white matter volume
year 3
Brain atrophy
Time Frame: year 4
measurement of global and regional grey matter volume measurement of global and regional white matter volume
year 4
Brain atrophy
Time Frame: year 5
measurement of global and regional grey matter volume measurement of global and regional white matter volume
year 5
Brain atrophy
Time Frame: MS onset assessed up to 2 years
measurement of global and regional grey matter volume measurement of global and regional white matter volume
MS onset assessed up to 2 years
Radiological progression : new T2 lesions
Time Frame: year 2
number of T2-weighted sequence
year 2
Radiological progression : new T2 lesions
Time Frame: year 2
localisation of interest of T2 lesion
year 2
Radiological progression : new T2 lesions
Time Frame: year 3
number of T2-weighted sequence
year 3
Radiological progression : new T2 lesions
Time Frame: year 4
localisation of interest of T2 lesion
year 4
Radiological progression : new T2 lesions
Time Frame: year 5
number of T2-weighted sequence
year 5
Radiological progression : new T2 lesions
Time Frame: MS onset assessed up to 2 years
localisation of interest of T2 lesion
MS onset assessed up to 2 years
Radiological progression : new contrast enhancing lesions
Time Frame: year 2
localisation of interest
year 2
Radiological progression : new contrast enhancing lesions
Time Frame: year 2
Lesions number
year 2
Radiological progression : new contrast enhancing lesions
Time Frame: year 3
Lesions number
year 3
Radiological progression : new contrast enhancing lesions
Time Frame: year 3
localisation of interest
year 3
Radiological progression : new contrast enhancing lesions
Time Frame: year 4
Lesions number
year 4
Radiological progression : new contrast enhancing lesions
Time Frame: year 4
localisation of interest
year 4
Radiological progression : new contrast enhancing lesions
Time Frame: year 5
Lesions number
year 5
Radiological progression : new contrast enhancing lesions
Time Frame: year 5
localisation of interest
year 5
Radiological progression : new contrast enhancing lesions
Time Frame: MS onset assessed up to 2 years
Lesions number
MS onset assessed up to 2 years
Radiological progression : new contrast enhancing lesions
Time Frame: MS onset assessed up to 2 years
localisation of interest
MS onset assessed up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Collect biological data
Time Frame: At inclusion
number of plasma samples
At inclusion
Collect biological data
Time Frame: MS onset assessed up to 2 years
number of plasma samples
MS onset assessed up to 2 years
Collect digital markers
Time Frame: at inclusion
The number of abnormalities identified by the eVOG application correlated with cerebral atrophy
at inclusion
Collect digital markers
Time Frame: year 1
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
year 1
Collect digital markers
Time Frame: year 2
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
year 2
Collect digital markers
Time Frame: year 3
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
year 3
Collect digital markers
Time Frame: year 4
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
year 4
Collect digital markers
Time Frame: year 5
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
year 5
Collect digital markers
Time Frame: MS onset assessed up to 2 years
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
MS onset assessed up to 2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22Neuro01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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