Multiple SclerosisNCT04380220
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
An observational study of Multiple Sclerosis and Relapse, run by Regina Elena Cancer Institute at 3 sites in 2 countries.
Trial summary
This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapse
- What is being tested?
- Blood samples and processing
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Sep 2017to 31 Dec 2020
- How long will I take part?
- 1 Month
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Relapsing-remitting multiple sclerosis patients and healthy subjects
Who may be able to join
- patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission
Who cannot join
- pregnant, with any neoplastic, hematologic, thyroid, metabolic, thrombotic or autoimmune disease, drug or alcohol addicted, treated with immunosuppressive drugs, steroids o any medication interfering with coagulation.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
IRCCS Regina Elena National Cancer Institute
Rome, 00144
University of Rome Sapienza
Rome, 00189
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC.
Patients and controls will be tested for either coagulation/complement (C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, factor II, aPTT, von-Willebrand factor), soluble markers of endothelial damage (thrombomodulin, Endothelial Protein C Receptor), antiphospholipid antibodies, lupus anticoagulant, complete blood count, viral serological assays or microRNA microarray.
Patients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume.
- Conditions
- Multiple Sclerosis, Relapse
- Being tested
- Blood samples and processing
- Keywords
- multiple sclerosis, relapse, coagulation, complement, cerebral blood flow
- Medical subject headings
- Multiple Sclerosis, Recurrence, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples and processingDiagnostic test
Also called complement C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, aPTT, factor II, v-Willebrand factor, thrombomodulin, Endothelial Protein C Receptor
DSC perfusion technique at 3.0-T MRI only in MS patients
| Study group | Role | What they receive |
|---|---|---|
| Relapsing MS patients | Patients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy. Receives: Diagnostic Test: Blood samples and processing | |
| Remitting MS patients | Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy. Receives: Diagnostic Test: Blood samples and processing | |
| Healthy controls | Age- and sex-matched healthy control subjects. Receives: Diagnostic Test: Blood samples and processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration of coagulation factor
Factor VIII (%)
Measured: through study completion, an average of 1 year
plasma concentration of coagulation factor
Factor X (%)
Measured: through study completion, an average of 1 year
plasma concentration of coagulation factor
D-dimer (ng/ml)
Measured: through study completion, an average of 1 year
plasma concentration of coagulation factor
Protein C (%)
Measured: through study completion, an average of 1 year
plasma concentration of coagulation factor
Protein S (%)
Measured: through study completion, an average of 1 year
plasma concentration of coagulation factor
Fibrinogen (mg/dl)
Measured: through study completion, an average of 1 year
plasma concentration of coagulation factor
complement (mg/dl)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Brain MRI hemodynamic changes at DSC 3.0-T MRI
cerebral blood flow
Measured: through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
cerebral blood volume
Measured: through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
mean transit time
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start7 Sep 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Tatiana Koudriavtseva, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380220
- Sponsor's protocol ID
- 972/17
- Other IDs
- PE-2013-02357745
- Status last verified
- May 2020
- First submitted
- 30 Apr 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koudriavtseva T, Lorenzano S, Cellerino M, Truglio M, Fiorelli M, Lapucci C, D'Agosto G, Conti L, Stefanile A, Zannino S, Filippi MM, Cortese A, Piantadosi C, Maschio M, Maialetti A, Galie E, Salvetti M, Inglese M. Tissue factor as a potential coagulative/vascular marker in relapsing-remitting multiple sclerosis. Front Immunol. 2023 Jul 31;14:1226616. doi: 10.3389/fimmu.2023.1226616. eCollection 2023.
PubMed 37583699Koudriavtseva T, Stefanile A, Fiorelli M, Lapucci C, Lorenzano S, Zannino S, Conti L, D'Agosto G, Pimpinelli F, Di Domenico EG, Mandoj C, Giannarelli D, Donzelli S, Blandino G, Salvetti M, Inglese M. Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-Remitting Multiple Sclerosis. Front Immunol. 2020 Oct 27;11:548604. doi: 10.3389/fimmu.2020.548604. eCollection 2020.
PubMed 33193314
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04380220
- Acronym / sponsor ID
- 972/17
- Conditions
- Multiple Sclerosis, Relapse
- Keywords
- multiple sclerosis, relapse, coagulation, complement, cerebral blood flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, Icahn School of Medicine at Mount Sinai
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 May 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.
This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC.
Patients and controls will be tested for either coagulation/complement (C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, factor II, aPTT, von-Willebrand factor), soluble markers of endothelial damage (thrombomodulin, Endothelial Protein C Receptor), antiphospholipid antibodies, lupus anticoagulant, complete blood count, viral serological assays or microRNA microarray.
Patients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Relapsing MS patients | – | Diagnostic Test: Blood samples and processingPatients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy. |
| Remitting MS patients | – | Diagnostic Test: Blood samples and processingPatients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy. |
| Healthy controls | – | Diagnostic Test: Blood samples and processingAge- and sex-matched healthy control subjects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Relapsing-remitting multiple sclerosis patients and healthy subjects
Key inclusion criteria (1 listed)
- patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission
Key exclusion criteria (1 listed)
- pregnant, with any neoplastic, hematologic, thyroid, metabolic, thrombotic or autoimmune disease, drug or alcohol addicted, treated with immunosuppressive drugs, steroids o any medication interfering with coagulation.
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 |
|---|---|---|
| Blood samples and processingAlso: complement C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, aPTT, factor II, v-Willebrand factor, thrombomodulin, Endothelial Protein C ReceptorDSC perfusion technique at 3.0-T MRI only in MS patients | Diagnostic test | Healthy controls, Relapsing MS patients, Remitting MS patients |
Primary outcome
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
Factor VIII (%)
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
Factor X (%)
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
D-dimer (ng/ml)
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
Protein C (%)
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
Protein S (%)
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
Fibrinogen (mg/dl)
plasma concentration of coagulation factor
Time frame: through study completion, an average of 1 year
complement (mg/dl)
3 secondary outcomes
Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time frame: through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time frame: through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: PubMed 37583699Koudriavtseva T, Lorenzano S, Cellerino M, Truglio M, Fiorelli M, Lapucci C, D'Agosto G, Conti L, Stefanile A, Zannino S, Filippi MM, Cortese A, Piantadosi C, Maschio M, Maialetti A, Galie E, Salvetti M, Inglese M. Tissue factor as a potential coagulative/vascular marker in relapsing-remitting multiple sclerosis. Front Immunol. 2023 Jul 31;14:1226616. doi: 10.3389/fimmu.2023.1226616. eCollection 2023.
- Derived from this study: PubMed 33193314Koudriavtseva T, Stefanile A, Fiorelli M, Lapucci C, Lorenzano S, Zannino S, Conti L, D'Agosto G, Pimpinelli F, Di Domenico EG, Mandoj C, Giannarelli D, Donzelli S, Blandino G, Salvetti M, Inglese M. Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-Remitting Multiple Sclerosis. Front Immunol. 2020 Oct 27;11:548604. doi: 10.3389/fimmu.2020.548604. eCollection 2020.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Relapse, run by Regina Elena Cancer Institute at 3 sites in 2 countries.
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 1 inclusion and 1 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 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, United States. 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?
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?
plasma concentration of coagulation factor (time frame: through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380220, which also lists 2 linked publications.
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 21 May 2020.