Clinically Isolated SyndromeOBITNCT03979391
Isoelectric Focusing of Tears in Children With Radiologically Isolated or Clinically Isolated Syndrome
A study testing Tear collection and lumbar punction in people with Clinically Isolated Syndrome and Radiologically Isolated Syndrome, run by Lille Catholic University at 1 site in France.
Trial summary
The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis in Children
- What is being tested?
- Tear collection and lumbar punction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2019to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age < 18 years old
- informed consent from the child and the parents (at least one of the two legal guardians)
- child covered by social security
- For the RIS population:
- asymptomatic child
- fortuitous discovery of lesions strongly suggesting sclerosis multiple on a Magnetic resonance imaging (MRI) scan
- For the CIS population:
- child presenting a CIS in the past three months
Who cannot join
- patient with remitting MS
- patient with progressive MS
- patient with eye infection
- patient under immunosuppressive therapy on the day of inclusion due to the treatment of another disease than MS
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GHICL
Lomme, 59462
Marie Paule Lebitasy, PhD, 00 33 3.20.22.57.41, Lebitasy.Marie-Paule@ghicl.net
Duriez
About this study
Official title: Detecting Oligoclonal Bands Through Isoelectric Focusing of Tears in Children With Radiologically Isolated Syndrome or Clinically Isolated Syndrome: a Diagnostic, Prospective, Multicentric Study With a 2-year Longitudinal Follow-up
The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.
Read the detailed description
Multiple Sclerosis (MS) is a disease that affects the white matter of the central nervous system. In France, approximately 100,000 patients are affected. It is one of the most common neurological condition in young adults.
The presence of supernumerary oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) in comparison to the serum was established in 2017 as a criterion for temporal dissemination in MS patients. This is a predictive factor of conversion to MS in the clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS), either in children or adults.
However, the main inconvenient of OCB analysis in CSF is the requirement of a lumbar puncture, which is a traumatising technique that may raise ethical concerns especially when it has to be performed in children.
Searching for OCBs in tears, which are more accessible, may represent an attractive alternative. Some published articles studying adult populations go in this direction, but there are no data in the literature regarding children.
The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.
- Conditions
- Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis in Children
- Being tested
- Tear collection and lumbar punction
- Keywords
- Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis, Children, Tear analysis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear collection and lumbar punctionDiagnostic test
Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands
| Study group | Role | What they receive |
|---|---|---|
| Children with CIS or RIS | Experimental | The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed Receives: Diagnostic Test: Tear collection and lumbar punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Measured: Day 0
Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Measured: Day 0
Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Measured: Day 0
Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Measured: Day 0
Secondary outcomes (1)
Proportion of patients with OCBs in tears
Measured: day 0, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start26 Sep 2019
- Primary completion26 Nov 2024 (estimated)
- Study completion26 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Isolated SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hautecoeur Patrick, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979391
- Sponsor's protocol ID
- RC-P0070
- Acronym
- OBIT
- Status last verified
- Sep 2023
- First submitted
- 3 Jun 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Oligoclonal Bands Through Isoelectric Focusing of Tears in Children With Radiologically Isolated Syndrome or Clinically Isolated Syndrome: a Diagnostic, Prospective, Multicentric Study With a 2-year Longitudinal Follow-up
- ClinicalTrials.gov ID
- NCT03979391
- Acronym / sponsor ID
- OBIT / RC-P0070
- Conditions
- Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis in Children
- Keywords
- Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis, Children, Tear analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 26 Nov 2024 (estimated)
- Study completion
- 26 Nov 2024 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.
Detailed description
Multiple Sclerosis (MS) is a disease that affects the white matter of the central nervous system. In France, approximately 100,000 patients are affected. It is one of the most common neurological condition in young adults.
The presence of supernumerary oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) in comparison to the serum was established in 2017 as a criterion for temporal dissemination in MS patients. This is a predictive factor of conversion to MS in the clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS), either in children or adults.
However, the main inconvenient of OCB analysis in CSF is the requirement of a lumbar puncture, which is a traumatising technique that may raise ethical concerns especially when it has to be performed in children.
Searching for OCBs in tears, which are more accessible, may represent an attractive alternative. Some published articles studying adult populations go in this direction, but there are no data in the literature regarding children.
The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with CIS or RIS | Experimental | Diagnostic Test: Tear collection and lumbar punctionThe detection of supernumerary oligoclonal bands (OCBs) in tears will be performed |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- age < 18 years old
- informed consent from the child and the parents (at least one of the two legal guardians)
- child covered by social security
- asymptomatic child
- fortuitous discovery of lesions strongly suggesting sclerosis multiple on a Magnetic resonance imaging (MRI) scan
Key exclusion criteria (4 listed)
- patient with remitting MS
- patient with progressive MS
- patient with eye infection
- patient under immunosuppressive therapy on the day of inclusion due to the treatment of another disease than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear collection and lumbar punctionTear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands | Diagnostic test | Children with CIS or RIS |
Primary outcome
Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
Time frame: Day 0
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
Time frame: Day 0
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
Time frame: Day 0
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
Time frame: Day 0
To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis
1 secondary outcome
Proportion of patients with OCBs in tears
Time frame: day 0, one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hautecoeur Patrick principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tear collection and lumbar punction in people with Clinically Isolated Syndrome and Radiologically Isolated Syndrome, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lebitasy Marie Paule, PhD (03.20.22.57.41, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.