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| Name | Class |
|---|---|
| Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG | UNKNOWN |
| Monogram Biosciences (LabCorp Specialty Testing Group) | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum Neurofilament Light | Diagnostic Test | The purpose of this research is to investigate a biomarker, called serum neurofilament light (sNfL), which is measured in blood. This study will attempt to investigate whether or not sNfL is a useful tool for clinicians in patients diagnosed with relapsing remitting multiple sclerosis. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | This outcome is based on structured clinician questionnaires developed for this study. Prior to receiving patient sNfL results, clinicians will answer the question "My current clinical impression of this patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)." After receiving patient sNfL results, clinicians will answer the question "After reviewing this patient's sNfL results along with other diagnostic testing at this time, my opinion of the patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)" and these answers will be reported. | 1 year |
| 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 | This outcome is based on a structured clinician questionnaire developed for this study. Clinicians will answer the question: "This patient's sNfL results have had the following impact on my opinions or confidence in this patient's care plan, or have potential to guide my clinical practice in the following way (please list specifics, e.g., increased confidence in assessment of disease status; decision to order additional testing; change in mediation therapy; change in frequency of follow-up, etc)" and these answers will be reported. | 1 year |
| Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements. | 1 year | |
| Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements. | This outcome is based on a structured clinician questionnaire developed for this study. Prior to receiving patient's sNfL results, clinicians will answer the question, "Is this an unscheduled sNfL measurement? Yes No; If yes, please specify reason why this sNfL measurement was scheduled" and these answers will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Describe patient demographics | 1 year | |
| Describe patient comorbidities | 1 year | |
| Describe patient concomitant medications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with relapsing remitting multiple sclerosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 1 year |
| Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. | After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "Knowledge of sNfL level has the potential to be useful in my clinical practice for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely." | 1 year |
| Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. | After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "sNfL results has the potential to be a useful/suitable alternative to MRI for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely." | 1 year |
| 1 year |
| Describe patient MS medications | 1 year |
| Describe patient reasons for MS medication changes | 1 year |
| Describe patient MS relapses including date of relapse | 1 year |
| Describe patient MS relapses including clinical findings | 1 year |
| Describe patient MS relapses including radiologic findings | 1 year |
| Describe patient MS relapses including severity | Severity of MS relapses will be described by change in EDSS score from non-relapsing EDSS measurement. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more accessible: ____________ " and these answers will be reported. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more burdensome: ___________" and these answers will be reported. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more uncomfortable: ___________" and these answers will be reported. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were easier to fit into my schedule: ____________" and these answers will be reported. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL results were more difficult to understand: ____________" and these answers will be reported. | 1 year |
| 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. | This outcome is based on structured patient questionnaires developed for this study. Patients will answer the following question before and after receiving sNfL results: "My current understanding of my MS disease is that I am (circle one): a. Stable, b. Experiencing increased disease activity, c. At risk for relapse, d. Experiencing a relapse, e. Unknown" and these answers will be reported. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? sNfL results were easy to understand: _______" and these results will be reported. | 1 year |
| Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. | This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? sNfL results increased my knowledge of my MS disease status: ____________" and these results will be reported. | 1 year |
| 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. | 1 year |
| 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. | 1 year |
| Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not. | 1 year |
| Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. | EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS. | 1 year |
| Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. | SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct. | 1 year |
| Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. | PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression. | 1 year |
| Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. | 1 year |
| Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. | 1 year |
| Describe changes in sNfL levels with magnetic resonance imaging disease activity where available. | 1 year |
| Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. | 1 year |
| Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. | EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS. | 1 year |
| Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. | SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct. | 1 year |
| Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. | PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression. | 1 year |
| Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. | 1 year |
| Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. | 1 year |
| Compare changes in sNfL levels with magnetic resonance imaging disease activity where available. | 1 year |
| Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. | 1 year |
| Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. | 1 year |
| Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. | SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct. | 1 year |
| Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. | PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression. | 1 year |
| Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. | 1 year |
| Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. | MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life. | 1 year |
| Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available. | 1 year |
| Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. | 1 year |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |