Multiple SclerosisTRAP-MyélineNCT01723631
Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
A study testing Trap Myelin Test in people with Multiple Sclerosis, run by Nantes University Hospital at 11 sites in France.
Trial summary
The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Trap Myelin Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 11 sitesFrance
- Study dates
- Apr 2012to Oct 2015
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- These criteria depend on the subgroup belongs to the patient.
- Signed consent
- Membership of a social security system
Who cannot join
- Whatever the patient group or control:
- Processing immunosuppressive.
- Processing by a monoclonal antibody.
- Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
- Carcinomatous pathology known evolving.
- People under guardianship.
- Pregnant women.
- Patients not motivated to study. Known patients with anemia (hemoglobin <10g/100ml)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
University Hospital of Bordeaux
Bordeaux
Hopital neurologigue Pierre Wertheimer
Bron
University Hospital of clermont Ferrand
Clermont-Ferrand
University Hospital of Lille
Lille
University Hospital of Marseille
Marseille
University Hospital of Montpellier
Montpellier
University Hospital of Nantes
Nantes
University Hospital of Nice
Nice
University Hospital of Rennes
Rennes
University Hospital of Strasbourg
Strasbourg
University Hospital of Toulouse
Toulouse
About this study
Official title: Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,
- Conditions
- Multiple Sclerosis
- Being tested
- Trap Myelin Test
- Keywords
- Multiple sclerosis, TRAP, TRAP-Myéline
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trap Myelin TestDevice
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Multiple Sclerosis- group 1 | Other | Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months. Receives: Device: Trap Myelin Test |
| Relapsing Multiple Sclerosis- group 2 | Other | Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months. Receives: Device: Trap Myelin Test |
| secondary progressive multiple sclerosis- Group 3 | Other | Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis Receives: Device: Trap Myelin Test |
| primary progressive multiple sclerosis- group 4 | Other | Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis Receives: Device: Trap Myelin Test |
| control 1 | Other | healthy volunteers Receives: Device: Trap Myelin Test |
| Control 2 | Other | Patients with central or peripheral neurological non-inflammatory, non-autoimmune. Receives: Device: Trap Myelin Test |
| Control 3 | Other | Patients having an autoimmune pathology Receives: Device: Trap Myelin Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
The main criterion corresponds to the area under the curve ROC (Receiver operating characteristic). The curve ROC is a graphic representation of the existing relation between the sensibility and the specificity of a test, calculated for all the values possible thresholds. The performance of the test TRAP-myéline will thus be estimated by means of the area calculated under this curve
Measured: 2 years
Secondary outcomes (1)
Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionOct 2015
Why it stopped: The number of patients achieved is sufficient to evaluate the diagnostic performance of the test TRAP-myelin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723631
- Sponsor's protocol ID
- BRD/10/06-S
- Other IDs
- 2010-A00892-37
- Acronym
- TRAP-Myéline
- Status last verified
- Dec 2014
- First submitted
- 6 Nov 2012
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01723631
- Acronym / sponsor ID
- TRAP-Myéline / BRD/10/06-S
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, TRAP, TRAP-Myéline
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of patients achieved is sufficient to evaluate the diagnostic performance of the test TRAP-myelin
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Nov 2012 (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.
The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Relapsing Multiple Sclerosis- group 1 | Other | Device: Trap Myelin TestDefinite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months. |
| Relapsing Multiple Sclerosis- group 2 | Other | Device: Trap Myelin TestMultiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months. |
| secondary progressive multiple sclerosis- Group 3 | Other | Device: Trap Myelin TestMultiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis |
| primary progressive multiple sclerosis- group 4 | Other | Device: Trap Myelin TestMultiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis |
| control 1 | Other | Device: Trap Myelin Testhealthy volunteers |
| Control 2 | Other | Device: Trap Myelin TestPatients with central or peripheral neurological non-inflammatory, non-autoimmune. |
| Control 3 | Other | Device: Trap Myelin TestPatients having an autoimmune pathology |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- These criteria depend on the subgroup belongs to the patient.
- Signed consent
- Membership of a social security system
Key exclusion criteria (8 listed)
- Whatever the patient group or control:
- Processing immunosuppressive.
- Processing by a monoclonal antibody.
- Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
- Carcinomatous pathology known evolving.
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 |
|---|---|---|
| Trap Myelin Test | Device | Control 2, Control 3, Relapsing Multiple Sclerosis- group 1, Relapsing Multiple Sclerosis- group 2, control 1, primary progressive multiple sclerosis- group 4, secondary progressive multiple sclerosis- Group 3 |
Primary outcome
Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
Time frame: 2 years
The main criterion corresponds to the area under the curve ROC (Receiver operating characteristic). The curve ROC is a graphic representation of the existing relation between the sensibility and the specificity of a test, calculated for all the values possible thresholds. The performance of the test TRAP-myéline will thus be estimated by means of the area calculated under this curve
1 secondary outcome
Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The number of patients achieved is sufficient to evaluate the diagnostic performance of the test TRAP-myelin). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trap Myelin Test in people with Multiple Sclerosis, run by Nantes University Hospital at 11 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: stopped early, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early (reason given: The number of patients achieved is sufficient to evaluate the diagnostic performance of the test TRAP-myelin). Results are not available in the source record.
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?
Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis (time frame: 2 years). 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 16 May 2017.