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/NCT06005246</url>
    </required_header>
    <id_info>
      <org_study_id>MUC-CFS</org_study_id>
      <nct_id>NCT06005246</nct_id>
    </id_info>
    <brief_title>Munich ME/CFS Cohort Study</brief_title>
    <acronym>MUC-CFS</acronym>
    <official_title>Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Technical University of Munich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Helmholtz Munich, Munich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>German Cancer Research Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Charité University Hospital, Berlin, Germany</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Technical University of Munich</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Munich cohort study MUC-CFS aims at the characterization and long-term follow-up of&#xD;
        myalgic encephalitis/chronic fatigue syndrome (ME/CFS) in young people aged up to 25 years,&#xD;
        as well as at the identification of pathomechanisms, biomarkers, and targets for future&#xD;
        treatment approaches.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        ME/CFS is a complex, chronic neurological disorder with an estimated pre-pandemic prevalence&#xD;
        of about 0.3%, affecting more people than multiple sclerosis (MS) worldwide. The number of&#xD;
        cases was reported to increase due to long-term sequelae of COVID-19 (post-COVID condition).&#xD;
        ME/CFS mainly affects young females aged 15-40 years but can occur in males and children. 25%&#xD;
        are mildly, 50% moderately, and 25% severely affected.&#xD;
  &#xD;
        Patients with ME/CFS suffer from fatigue, exertion intolerance with post-exertional malaise&#xD;
        (PEM), cognitive impairment, pain, sleep disturbances, autonomic, and neuroendocrine&#xD;
        manifestations, and flu-like symptoms. ME/CFS accounts for many cases of long-term school or&#xD;
        work absences, with subsequent high social and economic burdens. The health-related quality&#xD;
        of life is lower than in other severe chronic diseases.&#xD;
  &#xD;
        Most ME/CFS cases are triggered by an infection-like event (so-called post-infection ME/CFS).&#xD;
        Prominent triggers of ME/CFS include Epstein-Barr virus-associated infectious mononucleosis&#xD;
        (EBV-IM) and coronavirus disease 2019 (COVID-19). Moreover, cases following other infectious&#xD;
        diseases (e.g., other COVID, Influenza, Dengue fever, Ebola) are well documented.&#xD;
  &#xD;
        Possible mechanisms contributing to the pathogenesis of ME/CFS include reactivation of latent&#xD;
        viral infections, chronic inflammation, and autoimmunity, resulting in metabolic,&#xD;
        neurological, and vascular dysregulation. However, no biomarker or causative treatment for&#xD;
        ME/CFS has been established yet.&#xD;
  &#xD;
        ME/CFS (ICD10 G93.3) affords appropriate differential diagnostics and is defined by clinical&#xD;
        criteria. The criteria most commonly used are the criteria for &quot;systemic exertion intolerance&#xD;
        disease (SEID) defined by the former Institute of Medicine (IOM) and the Canadian Consensus&#xD;
        Criteria (CCC). Adapted pediatric criteria have been suggested by the groups of P.C. Rowe and&#xD;
        L.A. Jason in the US.&#xD;
  &#xD;
        ME/CFS treatment includes comprehensive patient education regarding self-management&#xD;
        strategies (e.g., pacing, relaxation strategies, sleep hygiene) as well as pharmaceutical and&#xD;
        non-pharmaceutical approaches to palliate symptoms such as pain, sleep disorder, or&#xD;
        orthostatic intolerance. Appropriate psychosocial support for patients and their families is&#xD;
        essential. Follow-up studies indicated a better prognosis in children compared to adults.&#xD;
  &#xD;
        The MUC-CFS cohort study is recruiting patients from the MRI Chronic Fatigue Center for Young&#xD;
        People (MCFC) at the Technical University of Munich (TUM) and the Munich Municipal Hospital&#xD;
        (MüK) in Munich, Germany. The MCFC closely cooperates with the Charité Fatigue Center (CFC)&#xD;
        in Berlin, Germany, and has long-standing expertise in ME/CFS care and research.&#xD;
  &#xD;
        The MUC-CFS cohort study aims to collect comprehensive clinical data regarding medical&#xD;
        history, clinical and laboratory phenotypes, the trajectory of individual diseases,&#xD;
        health-related quality of life, education, and social participation. Clinical data are&#xD;
        derived from complex initial investigations at in- or out-patient visits as well as from&#xD;
        following telephone calls and from various questionnaires. Biosampling (blood, urine, and/or&#xD;
        mouthwashes) takes place at any personal visit for later cell-analytical, molecular, and/or&#xD;
        biochemical analyses by our study group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 22, 2019</start_date>
    <completion_date type="Anticipated">January 2029</completion_date>
    <primary_completion_date type="Anticipated">January 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>Extensive Phenotyping of ME/CFS Patients</measure>
      <time_frame>5 years</time_frame>
      <description>Extensive phenotyping of children, adolescent, and young adult patients with post-infectious ME/CFS (e.g., age, gender, medical history, daily function, health-related quality of life, severity and frequency of symptoms, disease trajectory over time)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Risk factors</measure>
      <time_frame>5 years</time_frame>
      <description>Identification of risk factors for protracted courses without (partial) remission (e.g., age at symptom onset, sex, sociodemographic variables, medical history, medication, daily function at symptom onset, severity and frequency of symptoms at symptom onset, laboratory values, EBV serology, EBV DNA load).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers</measure>
      <time_frame>5 years</time_frame>
      <description>Identification of diagnostic biomarkers, i.e., a single and/or a combination of which, indicative of post-infectious ME/CFS (e.g., inflammatory markers, autoantibodies, EBV serology, EBV DNA load).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The number of study participants will not be limited.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written consent of the patient (or legal guardian for patients aged &lt; 18 years).&#xD;
  &#xD;
            -  Age 0 - 25 (including)&#xD;
  &#xD;
            -  Documented or probable acute infectious disease at the onset of ME/CFS symptoms&#xD;
  &#xD;
            -  Diagnosis of ME/CFS according to the IOM criteria, the CCC, the diagnostic worksheet&#xD;
               published by P.C. Rowe et al. (2017), or the pediatric case definition published by&#xD;
               L.A. Jason et al. (2006).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • drug/medication abuse, major surgery within the last six months, presence of organ&#xD;
          failure, post-stroke/craniocerebral trauma with cognitive deficits, post-intensive care&#xD;
          syndrome, syphilis, Lyme disease, AIDS, hepatitis B/C, multiple sclerosis, systemic lupus&#xD;
          erythematosus, Sjörgren's syndrome, malignancy, major depression or other severe&#xD;
          psychiatric illness, primary sleep disorder, severe endocrine disease (e.g.,&#xD;
          hypopituitarism, adrenal insufficiency), and other conditions that might explain ME/CFS&#xD;
          symptoms.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>25 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Uta Behrends, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>München Klinik Schwabing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Uta Behrends, Prof. Dr.</last_name>
      <phone>+49 89 4140 2632</phone>
      <email>uta.behrends@mri.tum.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kirstin Mittelstraß, Dr.</last_name>
      <phone>+49 89 4140 3046</phone>
      <email>kirstin.mittelstrass@mri.tum.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>MRI Chronic Fatigue Center for Young People (MCFC), Children's hospital, Technical University of Munich (TUM) and Munic Municipal Hospital (MüK)</name>
        <address>
          <city>Munich</city>
          <state>Bavaria</state>
          <zip>80804</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Uta Behrends, Prof. Dr.</last_name>
        <email>uta.behrends@mri.tum.de</email>
      </contact>
      <contact_backup>
        <last_name>Kirstin Mittelstraß, Dr.</last_name>
        <email>kirstin.mittelstrass@mri.tum.de</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>https://www.mri.tum.de/chronische-fatigue-centrum-fuer-junge-menschen-mcfc</url>
      <description>Homepage of the MRI Chronic Fatigue Center for Young People (MCFC)</description>
    </link>
    <reference>
      <citation>Pricoco R, Meidel P, Hofberger T, Zietemann H, Mueller Y, Wiehler K, Michel K, Paulick J, Leone A, Haegele M, Mayer-Huber S, Gerrer K, Mittelstrass K, Scheibenbogen C, Renz-Polster H, Mihatsch L, Behrends U. One-Year Follow-up of Young People with ME/CFS Following Infectious Mononucleosis by Epstein-Barr Virus. medRxiv 2023.07.24.23293082. doi: https://doi.org/10.1101/2023.07.24.23293082</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ME/CFS</keyword>
    <keyword>CFS/ME</keyword>
    <keyword>SEID</keyword>
    <keyword>myalgic encephalomyelitis</keyword>
    <keyword>chronic fatigue syndrome</keyword>
    <keyword>infectious mononucleosis</keyword>
    <keyword>systemic exertion intolerance disease</keyword>
    <keyword>Epstein-Barr virus</keyword>
    <keyword>post-COVID-19-syndrome</keyword>
    <keyword>post-COVID-19 condition</keyword>
    <keyword>long COVID</keyword>
    <keyword>post-acute sequelae of COVID-19</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Encephalomyelitis</mesh_term>
      <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
      <mesh_term>Myalgia</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <!-- 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/NCT06005246
  org study id: MUC-CFS
  nct id: NCT06005246
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The Munich cohort study MUC-CFS aims at the characterization and long-term follow-up of
        myalgic encephalitis/chronic fatigue syndrome (ME/CFS) in young people aged up to 25 years,
        as well as at the identification of pathomechanisms, biomarkers, and targets for future
        treatment approaches.
  ME/CFS is a complex, chronic neurological disorder with an estimated pre-pandemic prevalence
        of about 0.3%, affecting more people than multiple sclerosis (MS) worldwide. The number of
        cases was reported to increase due to long-term sequelae of COVID-19 (post-COVID condition).
        ME/CFS mainly affects young females aged 15-40 years but can occur in males and children. 25%
        are mildly, 50% moderately, and 25% severely affected.
  
        Patients with ME/CFS suffer from fatigue, exertion intolerance with post-exertional malaise
        (PEM), cognitive impairment, pain, sleep disturbances, autonomic, and neuroendocrine
        manifestations, and flu-like symptoms. ME/CFS accounts for many cases of long-term school or
        work absences, with subsequent high social and economic burdens. The health-related quality
        of life is lower than in other severe chronic diseases.
  
        Most ME/CFS cases are triggered by an infection-like event (so-called post-infection ME/CFS).
        Prominent triggers of ME/CFS include Epstein-Barr virus-associated infectious mononucleosis
        (EBV-IM) and coronavirus disease 2019 (COVID-19). Moreover, cases following other infectious
        diseases (e.g., other COVID, Influenza, Dengue fever, Ebola) are well documented.
  
        Possible mechanisms contributing to the pathogenesis of ME/CFS include reactivation of latent
        viral infections, chronic inflammation, and autoimmunity, resulting in metabolic,
        neurological, and vascular dysregulation. However, no biomarker or causative treatment for
        ME/CFS has been established yet.
  
        ME/CFS (ICD10 G93.3) affords appropriate differential diagnostics and is defined by clinical
        criteria. The criteria most commonly used are the criteria for "systemic exertion intolerance
        disease (SEID) defined by the former Institute of Medicine (IOM) and the Canadian Consensus
        Criteria (CCC). Adapted pediatric criteria have been suggested by the groups of P.C. Rowe and
        L.A. Jason in the US.
  
        ME/CFS treatment includes comprehensive patient education regarding self-management
        strategies (e.g., pacing, relaxation strategies, sleep hygiene) as well as pharmaceutical and
        non-pharmaceutical approaches to palliate symptoms such as pain, sleep disorder, or
        orthostatic intolerance. Appropriate psychosocial support for patients and their families is
        essential. Follow-up studies indicated a better prognosis in children compared to adults.
  
        The MUC-CFS cohort study is recruiting patients from the MRI Chronic Fatigue Center for Young
        People (MCFC) at the Technical University of Munich (TUM) and the Munich Municipal Hospital
        (MüK) in Munich, Germany. The MCFC closely cooperates with the Charité Fatigue Center (CFC)
        in Berlin, Germany, and has long-standing expertise in ME/CFS care and research.
  
        The MUC-CFS cohort study aims to collect comprehensive clinical data regarding medical
        history, clinical and laboratory phenotypes, the trajectory of individual diseases,
        health-related quality of life, education, and social participation. Clinical data are
        derived from complex initial investigations at in- or out-patient visits as well as from
        following telephone calls and from various questionnaires. Biosampling (blood, urine, and/or
        mouthwashes) takes place at any personal visit for later cell-analytical, molecular, and/or
        biochemical analyses by our study group.
  observational model: Cohort
  time perspective: Prospective
  measure: Extensive Phenotyping of ME/CFS Patients
  time frame: 5 years
  description: Extensive phenotyping of children, adolescent, and young adult patients with post-infectious ME/CFS (e.g., age, gender, medical history, daily function, health-related quality of life, severity and frequency of symptoms, disease trajectory over time)
  measure: Risk factors
  time frame: 5 years
  description: Identification of risk factors for protracted courses without (partial) remission (e.g., age at symptom onset, sex, sociodemographic variables, medical history, medication, daily function at symptom onset, severity and frequency of symptoms at symptom onset, laboratory values, EBV serology, EBV DNA load).
  measure: Biomarkers
  time frame: 5 years
  description: Identification of diagnostic biomarkers, i.e., a single and/or a combination of which, indicative of post-infectious ME/CFS (e.g., inflammatory markers, autoantibodies, EBV serology, EBV DNA load).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 25 Years
  last name: Uta Behrends, Prof. Dr.
  role: Principal Investigator
  affiliation: München Klinik Schwabing
  last name: Uta Behrends, Prof. Dr.
  phone: +49 89 4140 2632
  email: uta.behrends@mri.tum.de
  last name: Kirstin Mittelstraß, Dr.
  phone: +49 89 4140 3046
  email: kirstin.mittelstrass@mri.tum.de
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Germany
  url: https://www.mri.tum.de/chronische-fatigue-centrum-fuer-junge-menschen-mcfc
  description: Homepage of the MRI Chronic Fatigue Center for Young People (MCFC)
  citation: Pricoco R, Meidel P, Hofberger T, Zietemann H, Mueller Y, Wiehler K, Michel K, Paulick J, Leone A, Haegele M, Mayer-Huber S, Gerrer K, Mittelstrass K, Scheibenbogen C, Renz-Polster H, Mihatsch L, Behrends U. One-Year Follow-up of Young People with ME/CFS Following Infectious Mononucleosis by Epstein-Barr Virus. medRxiv 2023.07.24.23293082. doi: https://doi.org/10.1101/2023.07.24.23293082
  responsible party type: Sponsor
  mesh term: Encephalomyelitis
  mesh term: Fatigue Syndrome, Chronic
  mesh term: Myalgia
  mesh term: Syndrome
  mesh term: Fatigue