Clinically Isolated SyndromePOLARNCT02043964
Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion
A study testing tears and cerebrospinal fluid sampling in people with Clinically Isolated Syndrome and Multiple Sclerosis, run by Lille Catholic University at 15 sites in France.
Trial summary
This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinically Isolated Syndrome, Multiple Sclerosis
- What is being tested?
- tears and cerebrospinal fluid sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 15 sitesFrance
- Study dates
- Oct 2012to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or more
- Clinically isolated syndrome of less than 3 months of onset
- Informed consent to participate
Who cannot join
- Progressive primary multiple sclerosis
- Relapsing remitting multiple sclerosis
- Persons wearing contact lenses
- Ocular Infection
- Corticoid treatment at least 30 days before sampling
- Immunosuppressive or immunomodulatory treatment at least 3 months before sampling
- Pregnancy or breast feeding
- No coverage by the Social Insurance
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33300
Centre Hospitalier Universitaire Caen
Caen, 14000
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
Centre Hospitalier Universitaire de Dijon
Dijon, 21000
Centre Hospitalier Régional Universitaire de Lille
Lille, 59000
Groupe Hospitalier de l'Institut Catholique de Lille
Lomme, 59 462
Centre Hospitalier Universitaire de Lyon
Lyon, 69000
Hopital de la Timone
Marseille, 13000
Universitaire de Nancy
Nancy, 54100
Centre Hospitalier Universitaire de Nantes
Nantes, 44200
Centre Hospitalier Universitaire de Nice
Nice, 6200
Centre Hospitalier Intercommunal Poissy-St-Germain
Poissy, 78300
Centre Hospitalier Univetrsitaire de Rouen
Rouen, 76100
Centre Hospitalier Régional Universitaire de Strasbourg
Strasbourg, 67100
Centre Hospitalier de Valenciennes
Valenciennes, 59300
About this study
Official title: Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)
This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.
- Conditions
- Clinically Isolated Syndrome, Multiple Sclerosis
- Being tested
- tears and cerebrospinal fluid sampling
- Keywords
- Multiple Sclerosis, Clinically Isolated Syndrome, Tears, Isoelectric focusing, Oligoclonal profile
- Medical subject headings
- Multiple Sclerosis, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tears and cerebrospinal fluid samplingProcedure or surgery
All patients recruited in this study will undergo a cerebrospinal fluid sampling which is an invasive procedure included in the actual routine practice. In addition a sampling from eyes will be obtain using the Schirmer test to get tears from the lacrimal gland.
| Study group | Role | What they receive |
|---|---|---|
| tears and cerebro-spinal fluid sampling | Experimental | Not described Receives: Procedure: tears and cerebrospinal fluid sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
Measured: two years after
Secondary outcomes (5)
Diagnostic performance of isoelectric focusing of tears
Identification of the number of patients with a typical electrophoretic profile in tears allowing the early diagnosis of a SEP-RR
Measured: inclusion, two years after
Concordance between visual and automatic reading of electrophoretic profiles
Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles
Measured: two years
Calculation of sensitivity/specificity
Calculation of sensitivity/specificity
Measured: two years
Calculation of positive/negative predictive value
Calculation of positive/negative predictive value
Measured: two years
Calculation of efficiency odds ratio
Calculation of efficiency odds ratio
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionJun 2018
- Study completionDec 2018
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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérard Forzy, MD, Study director, Groupement des Hôpitaux de l'Institut Catholique de LillePatrick Hautecoeur, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de LillePatrick Vermersch, MD, PhD, Principal investigator, Centre Hospitalier Régional, Universitaire de LilleGilles Defer, MD, Principal investigator, Centre Hospitalier Universitaire de CaenChristine Lebrun-Fresnay, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de NiceJérôme de Seze, MD, PhD, Principal investigator, Centre Hospitalier Régional Universitaire de StrasbourgThibault Moreau, MD, Principal investigator, Centre Hospitalier Universitaire DijonPierre Clavelou, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043964
- Sponsor's protocol ID
- RC-P0021
- Acronym
- POLAR
- Status last verified
- Mar 2024
- First submitted
- 22 Nov 2013
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)
- ClinicalTrials.gov ID
- NCT02043964
- Acronym / sponsor ID
- POLAR / RC-P0021
- Conditions
- Clinically Isolated Syndrome, Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Clinically Isolated Syndrome, Tears, Isoelectric focusing, Oligoclonal profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Jan 2014 (estimated)
- 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.
This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tears and cerebro-spinal fluid sampling | Experimental | Procedure: tears and cerebrospinal fluid sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or more
- Clinically isolated syndrome of less than 3 months of onset
- Informed consent to participate
Key exclusion criteria (8 listed)
- Progressive primary multiple sclerosis
- Relapsing remitting multiple sclerosis
- Persons wearing contact lenses
- Ocular Infection
- Corticoid treatment at least 30 days before sampling
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 |
|---|---|---|
| tears and cerebrospinal fluid samplingAll patients recruited in this study will undergo a cerebrospinal fluid sampling which is an invasive procedure included in the actual routine practice. In addition a sampling from eyes will be obtain using the Schirmer test to get tears from the lacrimal gland. | Procedure or surgery | tears and cerebro-spinal fluid sampling |
Primary outcome
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
Time frame: two years after
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
5 secondary outcomes
Diagnostic performance of isoelectric focusing of tears
Time frame: inclusion, two years after
Concordance between visual and automatic reading of electrophoretic profiles
Time frame: two years
Calculation of sensitivity/specificity
Time frame: two years
Calculation of positive/negative predictive value
Time frame: two years
Calculation of efficiency odds ratio
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
Gérard Forzy, MD study director
Groupement des Hôpitaux de l'Institut Catholique de Lille
Patrick Hautecoeur, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
Patrick Vermersch, MD, PhD principal investigator
Centre Hospitalier Régional, Universitaire de Lille
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tears and cerebrospinal fluid sampling in people with Clinically Isolated Syndrome and Multiple Sclerosis, run by Lille Catholic University at 15 sites 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid (time frame: two years after). 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 26 Mar 2024.