nctId: NCT06282081 id: ML 45098 briefTitle: Serum Neurofilament Light in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-28 date: 2024-02-28 name: Dent Neuroscience Research Center class: OTHER name: Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG name: Monogram Biosciences (LabCorp Specialty Testing Group) 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. conditions: Multiple Sclerosis conditions: Relapsing Remitting Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: Serum Neurofilament Light 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 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 measure: Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements. measure: Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements. measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. measure: Describe patient demographics measure: Describe patient comorbidities measure: Describe patient concomitant medications measure: Describe patient MS medications measure: Describe patient reasons for MS medication changes measure: Describe patient MS relapses including date of relapse measure: Describe patient MS relapses including clinical findings measure: Describe patient MS relapses including radiologic findings measure: Describe patient MS relapses including severity measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. 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. measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. 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. 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. measure: Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not. measure: Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Describe changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. measure: Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Compare changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. measure: Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False