Multiple SclerosisCISCONCT04510350
Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
An observational study of Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
Trial summary
The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Biomarkers analysis
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2020to 2 Mar 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: After selection of the patients and volunteers of interest (number and type of clinical and biological data available, heterogeneity of the chosen group...), the medical and imaging data of the patients will be transmitted by OFSEP from the EDMUS database and for healthy volunteers, the data of interest will be retrieved from the ABCD-SEP database Patients CIS+ :60 Healthy Volunters : 30
Who may be able to join
- Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
- At least 18 years of age
- Diagnosed with MS according to criteria 2017 at the time of their last visit.
- Non-opposition to participation in the study
- Having had at least one visit in the year following collection
- Follow-up for at least 1 year after collection.
Show all 11Show fewer
- Having signed the OFSEP consent
- Age 18 years or older
- Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).
- Matched on age and sex to patients of interest in the OFSEP cohort
- Not having objected to participation in the study
Who cannot join
- CIS patients with progressive MS
- Healthy volunteers :
- Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Biomarkers 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.
Biomarkers analysisOther
Genetic analysis of regions of interest
| Study group | Role | What they receive |
|---|---|---|
| MS CIS+ | Not described Receives: Other: Biomarkers analysis | |
| Healthy volunteers | Not described Receives: Other: Biomarkers analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of immune subpopulations
Correlations between the frequency of immune subpopulations, genetic profile and disease activity
Measured: 1 year
Secondary outcomes (5)
Frequency of immune subpopulations correlated to EDSS score
Correlations between the frequency of immune subpopulations, genetic profile, and EDSS score ((Expanded Disability Status Scale, method of quantifying disability in multiple sclerosis, steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.)
Measured: 1 year
Frequency of immune subpopulations correlated to disease progression delay
Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression
Measured: 1 year
Frequency of immune subpopulations correlated to disease progression events
Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events
Measured: 1 year
Frequency of immune subpopulations correlated to spinal lesions
Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions
Measured: 1 year
Profiles of CIS+ patients
Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start19 Feb 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
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 Rennes 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Michel, Md, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510350
- Sponsor's protocol ID
- 35RC19_8880_CISCO
- Acronym
- CISCO
- Status last verified
- Mar 2022
- First submitted
- 10 Aug 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
- ClinicalTrials.gov ID
- NCT04510350
- Acronym / sponsor ID
- CISCO / 35RC19_8880_CISCO
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 12 Aug 2020 (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 objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS CIS+ | – | Other: Biomarkers analysis |
| Healthy volunteers | – | Other: Biomarkers analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- After selection of the patients and volunteers of interest (number and type of clinical and biological data available, heterogeneity of the chosen group...), the medical and imaging data of the patients will be transmitted by OFSEP from the EDMUS database and for healthy volunteers, the data of interest will be retrieved from the ABCD-SEP database Patients CIS+ :60 Healthy Volunters : 30
Key inclusion criteria (11 listed)
- Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
- At least 18 years of age
- Diagnosed with MS according to criteria 2017 at the time of their last visit.
- Non-opposition to participation in the study
- Having had at least one visit in the year following collection
Key exclusion criteria (3 listed)
- CIS patients with progressive MS
- Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
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 |
|---|---|---|
| Biomarkers analysisGenetic analysis of regions of interest | Other | Healthy volunteers, MS CIS+ |
Primary outcome
Frequency of immune subpopulations
Time frame: 1 year
Correlations between the frequency of immune subpopulations, genetic profile and disease activity
5 secondary outcomes
Frequency of immune subpopulations correlated to EDSS score
Time frame: 1 year
Frequency of immune subpopulations correlated to disease progression delay
Time frame: 1 year
Frequency of immune subpopulations correlated to disease progression events
Time frame: 1 year
Frequency of immune subpopulations correlated to spinal lesions
Time frame: 1 year
Profiles of CIS+ patients
Time frame: 1 year
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 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Laure Michel, Md principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Rennes University Hospital 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 11 inclusion and 3 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 3 Mar 2022. 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?
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?
Frequency of immune subpopulations (time frame: 1 year). 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 3 Mar 2022.