protocolSection identificationModule nctId: NCT06282081, orgStudyIdInfo id: ML 45098, briefTitle: Serum Neurofilament Light in Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dent Neuroscience Research Center, class: OTHER, collaborators name: Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG, collaborators name: Monogram Biosciences (LabCorp Specialty Testing Group), descriptionModule briefSummary: This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy., conditionsModule conditions: Multiple Sclerosis, conditions: Relapsing Remitting Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Serum Neurofilament Light, outcomesModule primaryOutcomes measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received, primaryOutcomes measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice, primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements., primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements., primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale., primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale., secondaryOutcomes measure: Describe patient demographics, secondaryOutcomes measure: Describe patient comorbidities, secondaryOutcomes measure: Describe patient concomitant medications, secondaryOutcomes measure: Describe patient MS medications, secondaryOutcomes measure: Describe patient reasons for MS medication changes, secondaryOutcomes measure: Describe patient MS relapses including date of relapse, secondaryOutcomes measure: Describe patient MS relapses including clinical findings, secondaryOutcomes measure: Describe patient MS relapses including radiologic findings, secondaryOutcomes measure: Describe patient MS relapses including severity, secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire., secondaryOutcomes measure: Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available., secondaryOutcomes measure: Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available., secondaryOutcomes measure: Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not., secondaryOutcomes measure: Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available., secondaryOutcomes measure: Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available., secondaryOutcomes measure: Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available., secondaryOutcomes measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available., secondaryOutcomes measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available., secondaryOutcomes measure: Describe changes in sNfL levels with magnetic resonance imaging disease activity where available., secondaryOutcomes measure: Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available., secondaryOutcomes measure: Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available., secondaryOutcomes measure: Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available., secondaryOutcomes measure: Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available., secondaryOutcomes measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available., secondaryOutcomes measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available., secondaryOutcomes measure: Compare changes in sNfL levels with magnetic resonance imaging disease activity where available., secondaryOutcomes measure: Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available., secondaryOutcomes measure: Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available., secondaryOutcomes measure: Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False