xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001138</url>
    </required_header>
    <id_info>
      <org_study_id>AC21029</org_study_id>
      <nct_id>NCT06001138</nct_id>
    </id_info>
    <brief_title>Multiple Sclerosis: FutureMS-2 - an Observational Cohort and Scottish Precision Medicine Study</brief_title>
    <official_title>FutureMS-2: Clinical, Laboratory, and Genomic Predictors of Disease Activity in People Diagnosed With Relapsing Onset Multiple Sclerosis: an Observational Cohort and Scottish Precision Medicine Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Edinburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>NHS Lothian</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Edinburgh</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        FutureMS is a project created in direct response to frequent questions people with MS ask&#xD;
        their doctors. Every person newly diagnosed wants to know how MS will affect them over their&#xD;
        life and what can be done to stop the disease progressing and improve their quality of life.&#xD;
        FutureMS aims to help answer those questions.&#xD;
  &#xD;
        The original FutureMS study provided a snapshot of the impact of MS within a year of&#xD;
        diagnosis. However, MS is a long-term condition and so the investigators now want to better&#xD;
        understand the impact of MS, on the same individuals, after approximately 5 and 10 years of&#xD;
        living with MS. This is the purpose of FutureMS-2.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        MS is a chronic incurable and devastating inflammatory - neurodegenerative disorder of the&#xD;
        central nervous system. There are an estimated 2.4M people with multiple sclerosis (pwMS).&#xD;
        Scotland has one of the highest prevalence for MS in the world with 240 per 100'000 of the&#xD;
        population having MS at any given time and with an incidence rate of 8.76 per 100'000. It is&#xD;
        the leading non-traumatic cause of neurological disability in young adults across the&#xD;
        industrialised world, and 85% of prevalent cases are in people of working age.&#xD;
  &#xD;
        Despite important advances in diagnostics and treatment for the newly diagnosed pwMS, there&#xD;
        remain major unsolved challenges. These include the inability to predict disease course and&#xD;
        prognosis for newly diagnosed patients. MS in this regard is distinct to other degenerative&#xD;
        brain diseases that have a uniform and predictable &quot;downward&quot; natural history. In contrast,&#xD;
        MS is inherently unpredictable and variable. For example, some pwMS will, without treatment,&#xD;
        experience a mild course with negligible disability after many years whilst others are&#xD;
        seriously disabled within a few years. Therefore, at the point of diagnosis of MS, today the&#xD;
        investigators are unable to predict whether the individual is destined to have mild,&#xD;
        intermediate or a severe disease course noting that the disease is chronic and plays out over&#xD;
        30+ years. Furthermore, the range of disabilities that pwMS endure are varied and many and&#xD;
        extend beyond physical disability. Yet, &quot;invisible&quot; but devastating disability including&#xD;
        fatigue, pain and cognition, remain poorly studied and understood. As a consequence of these&#xD;
        knowledge gaps, pwMS are unable to make informed lifestyle or treatment decision choices.&#xD;
        FutureMS aims to address these important knowledge gaps.&#xD;
  &#xD;
        Against this background, FutureMS supported by SMS Scotland was established (2015 - 2021).&#xD;
        FutureMS is a national inception cohort study of 440 newly diagnosed people with MS that&#xD;
        combines clinical, imaging, genomic, health and lifestyle data using a Scottish informatics&#xD;
        platform. FutureMS is very much a key plank of the wider ambition for Scotland to lead in the&#xD;
        area of precision medicine with a special focus on disorders, such as MS, with high morbidity&#xD;
        and cost to the individual and society. Scotland is ideally placed to lead in precision&#xD;
        medicine for MS. This reflects disproportionate per capita disease burden plus various&#xD;
        national assets including e-health infrastructural strengths, unitary single health provider,&#xD;
        single health identifier and 5 research intensive medical universities with many&#xD;
        world-leading researchers in both the laboratory and clinical science of MS. Many of these&#xD;
        researchers are also investigators in the MS Society Centre of Excellence - one of only two&#xD;
        UK flagship centres supported by the MS Society - based in Edinburgh (Director - Siddharthan&#xD;
        Chandran).&#xD;
  &#xD;
        Next phase for FutureMS - Wave 2. The ultimate objective of FutureMS-2 is to contribute to&#xD;
        the generation of validated and quantitative precision medicine tools that will allow&#xD;
        individualised disease course prediction and personalised treatment. To fully exploit this&#xD;
        national resource and realise its unprecedented value, there is a need to follow up the&#xD;
        FutureMS cohort over time and &quot;re-measure&quot; key metrics of disease activity and its impact on&#xD;
        the health and wealth of the individual. The wider goals of Wave 2 are to further drive the&#xD;
        agenda and ambition of 4Ps (prevent, personalise, predict and participate) medicine for MS.&#xD;
        It is the investigators' intention to grow, in particular, the &quot;participatory&quot; elements of&#xD;
        this programme working with and advised/guided by the FutureMS &quot;lived experience panel&quot;. This&#xD;
        study has been shaped by these discussions and details the scientific justification and&#xD;
        methodology to allow two follow up epochs of the original cohort at c.5 years (Wave 2) and&#xD;
        c.10 years after diagnosis (Wave 3). Eight-ten years is the approximate average time by which&#xD;
        the majority of individuals, without treatment, with RRMS will transition to the progressive&#xD;
        phase of MS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">October 7, 2021</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Disease activity defined by new or enlarging T2 hyperintense lesion count on MR brain imaging at 5 years and 10 years of diagnosis with relapsing-remitting MS</measure>
      <time_frame>at 5 and 10 years after diagnosis of relapsing - remitting MS</time_frame>
      <description>Primary objective</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease activity defined by the composite endpoint of new or enlarging T2 hyperintense lesions on MR brain imagingneurodegeneration and regenerative markers of disease activity</measure>
      <time_frame>at 5 and 10 years after diagnosis of relapsing - remitting MS</time_frame>
      <description>Co-secondary outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clinical relapse at 5 and 10 years of diagnosis with relapsing-remitting MS</measure>
      <time_frame>at 5 and 10 years after diagnosis of relapsing - remitting MS</time_frame>
      <description>Co-secondary outcome</description>
    </secondary_outcome>
    <enrollment type="Anticipated">440</enrollment>
    <condition>Multiple Sclerosis</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        plasma, serum, saliva&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The overwhelming majority (98%) of FutureMS participants have given consent to be&#xD;
          approached for future research. The study aims to retain 90% of the consented FutureMS&#xD;
          cohort. The majority of participants that took part in FutureMS gave their consent to be&#xD;
          contacted about future ethically approved research. These participants will be contact&#xD;
          directly by a phone, email or post by the study team.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Previous participants in FutureMS cohort&#xD;
  &#xD;
            -  Capacity to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not a participant of FutureMS inception cohort&#xD;
  &#xD;
            -  Contraindication to MR brain imaging&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Siddharthan Chandran, Professor</last_name>
      <role>Study Director</role>
      <affiliation>University of Edinburgh</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Aberdeen Clinical Research Facility Royal Cornhill Hospital</name>
        <address>
          <city>Aberdeen</city>
          <zip>AB25 2ZD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Dundee Clinical Research Centre Ninewells Hospital</name>
        <address>
          <city>Dundee</city>
          <zip>DD1 9SY</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Anne Rowling Regenerative Neurology Clinic</name>
        <address>
          <city>Edinburgh</city>
          <zip>EH16 4SB</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Glasgow Clinical Research Facility Queen Elizabeth University Hospital</name>
        <address>
          <city>Glasgow</city>
          <zip>G51 4TF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Centre for Health Sciences Raigmore Hospital</name>
        <address>
          <city>Inverness</city>
          <zip>IV2 3JH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <reference>
      <citation>Kearns PKA, Martin SJ, Chang J, Meijboom R, York EN, Chen Y, Weaver C, Stenson A, Hafezi K, Thomson S, Freyer E, Murphy L, Harroud A, Foley P, Hunt D, McLeod M, O'Riordan J, Carod-Artal FJ, MacDougall NJJ, Baranzini SE, Waldman AD, Connick P, Chandran S. FutureMS cohort profile: a Scottish multicentre inception cohort study of relapsing-remitting multiple sclerosis. BMJ Open. 2022 Jun 29;12(6):e058506. doi: 10.1136/bmjopen-2021-058506.</citation>
      <PMID>35768080</PMID>
    </reference>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>February 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>To ensure data transparency, the results of any closed comparisons will be published in a peer reviewed journal as soon as it is possible when the integrity of the study will not be affected.&#xD;
  Individual level participant data will be shared, after de-identification, upon receipt of a valid request.&#xD;
  Some data may be shared prior to the publication of study results depending on the requirements, however, no end point data will be released without explicit need.&#xD;
  Each data request form will be individually reviewed to ensure the proposal has a valid rationale and appropriate methodology. Only data required for the project will be shared.&#xD;
  A summary of results will be provided to all participants via newsletters and the Anne Rowling Clinic's website.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After publication of study results, no end date.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims of the proposal only.&#xD;
  Data sharing request forms are available from future-ms@ed.ac.uk. Requesters will need to sign a data access agreement prior to being provided with access to data.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001138
  org study id: AC21029
  nct id: NCT06001138
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  FutureMS is a project created in direct response to frequent questions people with MS ask
        their doctors. Every person newly diagnosed wants to know how MS will affect them over their
        life and what can be done to stop the disease progressing and improve their quality of life.
        FutureMS aims to help answer those questions.
  
        The original FutureMS study provided a snapshot of the impact of MS within a year of
        diagnosis. However, MS is a long-term condition and so the investigators now want to better
        understand the impact of MS, on the same individuals, after approximately 5 and 10 years of
        living with MS. This is the purpose of FutureMS-2.
  MS is a chronic incurable and devastating inflammatory - neurodegenerative disorder of the
        central nervous system. There are an estimated 2.4M people with multiple sclerosis (pwMS).
        Scotland has one of the highest prevalence for MS in the world with 240 per 100'000 of the
        population having MS at any given time and with an incidence rate of 8.76 per 100'000. It is
        the leading non-traumatic cause of neurological disability in young adults across the
        industrialised world, and 85% of prevalent cases are in people of working age.
  
        Despite important advances in diagnostics and treatment for the newly diagnosed pwMS, there
        remain major unsolved challenges. These include the inability to predict disease course and
        prognosis for newly diagnosed patients. MS in this regard is distinct to other degenerative
        brain diseases that have a uniform and predictable "downward" natural history. In contrast,
        MS is inherently unpredictable and variable. For example, some pwMS will, without treatment,
        experience a mild course with negligible disability after many years whilst others are
        seriously disabled within a few years. Therefore, at the point of diagnosis of MS, today the
        investigators are unable to predict whether the individual is destined to have mild,
        intermediate or a severe disease course noting that the disease is chronic and plays out over
        30+ years. Furthermore, the range of disabilities that pwMS endure are varied and many and
        extend beyond physical disability. Yet, "invisible" but devastating disability including
        fatigue, pain and cognition, remain poorly studied and understood. As a consequence of these
        knowledge gaps, pwMS are unable to make informed lifestyle or treatment decision choices.
        FutureMS aims to address these important knowledge gaps.
  
        Against this background, FutureMS supported by SMS Scotland was established (2015 - 2021).
        FutureMS is a national inception cohort study of 440 newly diagnosed people with MS that
        combines clinical, imaging, genomic, health and lifestyle data using a Scottish informatics
        platform. FutureMS is very much a key plank of the wider ambition for Scotland to lead in the
        area of precision medicine with a special focus on disorders, such as MS, with high morbidity
        and cost to the individual and society. Scotland is ideally placed to lead in precision
        medicine for MS. This reflects disproportionate per capita disease burden plus various
        national assets including e-health infrastructural strengths, unitary single health provider,
        single health identifier and 5 research intensive medical universities with many
        world-leading researchers in both the laboratory and clinical science of MS. Many of these
        researchers are also investigators in the MS Society Centre of Excellence - one of only two
        UK flagship centres supported by the MS Society - based in Edinburgh (Director - Siddharthan
        Chandran).
  
        Next phase for FutureMS - Wave 2. The ultimate objective of FutureMS-2 is to contribute to
        the generation of validated and quantitative precision medicine tools that will allow
        individualised disease course prediction and personalised treatment. To fully exploit this
        national resource and realise its unprecedented value, there is a need to follow up the
        FutureMS cohort over time and "re-measure" key metrics of disease activity and its impact on
        the health and wealth of the individual. The wider goals of Wave 2 are to further drive the
        agenda and ambition of 4Ps (prevent, personalise, predict and participate) medicine for MS.
        It is the investigators' intention to grow, in particular, the "participatory" elements of
        this programme working with and advised/guided by the FutureMS "lived experience panel". This
        study has been shaped by these discussions and details the scientific justification and
        methodology to allow two follow up epochs of the original cohort at c.5 years (Wave 2) and
        c.10 years after diagnosis (Wave 3). Eight-ten years is the approximate average time by which
        the majority of individuals, without treatment, with RRMS will transition to the progressive
        phase of MS.
  observational model: Cohort
  time perspective: Prospective
  measure: Disease activity defined by new or enlarging T2 hyperintense lesion count on MR brain imaging at 5 years and 10 years of diagnosis with relapsing-remitting MS
  time frame: at 5 and 10 years after diagnosis of relapsing - remitting MS
  description: Primary objective
  measure: Disease activity defined by the composite endpoint of new or enlarging T2 hyperintense lesions on MR brain imagingneurodegeneration and regenerative markers of disease activity
  time frame: at 5 and 10 years after diagnosis of relapsing - remitting MS
  description: Co-secondary outcome
  measure: clinical relapse at 5 and 10 years of diagnosis with relapsing-remitting MS
  time frame: at 5 and 10 years after diagnosis of relapsing - remitting MS
  description: Co-secondary outcome
  plasma, serum, saliva
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Siddharthan Chandran, Professor
  role: Study Director
  affiliation: University of Edinburgh
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United Kingdom
  citation: Kearns PKA, Martin SJ, Chang J, Meijboom R, York EN, Chen Y, Weaver C, Stenson A, Hafezi K, Thomson S, Freyer E, Murphy L, Harroud A, Foley P, Hunt D, McLeod M, O'Riordan J, Carod-Artal FJ, MacDougall NJJ, Baranzini SE, Waldman AD, Connick P, Chandran S. FutureMS cohort profile: a Scottish multicentre inception cohort study of relapsing-remitting multiple sclerosis. BMJ Open. 2022 Jun 29;12(6):e058506. doi: 10.1136/bmjopen-2021-058506.
  PMID: 35768080
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: Yes
  ipd description: To ensure data transparency, the results of any closed comparisons will be published in a peer reviewed journal as soon as it is possible when the integrity of the study will not be affected.
  Individual level participant data will be shared, after de-identification, upon receipt of a valid request.
  Some data may be shared prior to the publication of study results depending on the requirements, however, no end point data will be released without explicit need.
  Each data request form will be individually reviewed to ensure the proposal has a valid rationale and appropriate methodology. Only data required for the project will be shared.
  A summary of results will be provided to all participants via newsletters and the Anne Rowling Clinic's website.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: After publication of study results, no end date.
  ipd access criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims of the proposal only.
  Data sharing request forms are available from future-ms@ed.ac.uk. Requesters will need to sign a data access agreement prior to being provided with access to data.