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NCT04495556 · ClinicalTrials.gov registry record

Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

A clinical trial of Multiple Sclerosis, sponsored by The Cleveland Clinic.

Active
Registry status
420
Enrollment target
11
Study locations

NCT04495556 is a study of Multiple Sclerosis that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 420 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (28% lower). The trial reports 11 study locations across 10 states.

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The verdict

NCT04495556, a study of Multiple Sclerosis, is active but no longer recruiting, sponsored by The Cleveland Clinic.

ACTIVE NOT RECRUITING
Registry status
420 participants
Enrollment target
11
Study locations

Study Summary

The need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.

Conditions Studied

Multiple Sclerosis

Interventions

  • DIAGNOSTIC_TEST MRI

Study Locations (11)

California

  • Cedars-Sinai Medical Center - Los Angeles
  • University of Southern California - Los Angeles

Colorado

  • University of Colorado - Aurora

Connecticut

  • Yale University - New Haven

Maryland

  • Johns Hopkins University - Baltimore

Missouri

  • Washington University in St. Louis - St Louis

Ohio

  • Cleveland Clinic Foundation - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Texas

  • The University of Texas at Austin - Austin

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2020-06-11
Est. Completion 2027-01

Sponsor

The Cleveland Clinic

688 total trials

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What the Registry Record Tells You About NCT04495556

The ClinicalTrials.gov registry entry for NCT04495556 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (28% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which MRI is the first listed.

NCT04495556 reports 11 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Connecticut.

Frequently Asked Questions

What is clinical trial NCT04495556 about?

NCT04495556 is a clinical study titled "Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis". The need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease...

What is the current status of trial NCT04495556?

This trial is currently active not recruiting. The enrollment target is 420 participants. The study started on 2020-06-11. Estimated completion is 2027-01.

What conditions does trial NCT04495556 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT04495556?

The interventions under investigation include: MRI (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04495556?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04495556 being conducted?

This trial has 11 study locations across California, Colorado, Connecticut, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.