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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04380220
Other study ID # 972/17
Secondary ID PE-2013-02357745
Status Active, not recruiting
Phase
First received
Last updated
Start date September 7, 2017
Est. completion date December 31, 2020

Study information

Verified date May 2020
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients

Locations

Country Name City State
Italy IRCCS Regina Elena National Cancer Institute Rome
Italy University of Rome Sapienza Rome
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (3)

Lead Sponsor Collaborator
Regina Elena Cancer Institute Icahn School of Medicine at Mount Sinai, University of Roma La Sapienza

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma concentration of coagulation factor Factor VIII (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Factor X (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor D-dimer (ng/ml) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Protein C (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Protein S (%) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor Fibrinogen (mg/dl) through study completion, an average of 1 year
Primary plasma concentration of coagulation factor complement (mg/dl) through study completion, an average of 1 year
Secondary Brain MRI hemodynamic changes at DSC 3.0-T MRI cerebral blood flow through study completion, an average of 1 year
Secondary Brain MRI hemodynamic changes at DSC 3.0-T MRI cerebral blood volume through study completion, an average of 1 year
Secondary Brain MRI hemodynamic changes at DSC 3.0-T MRI mean transit time through study completion, an average of 1 year
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