Clinical trial NCT05778006: Multi-Center Registry for ME/CFS
Official title: Multi-Center Registry for ME/CFS, Including ME/CFS Following Epstein-Barr Virus-Associated Infectious Mononucleosis (EBV-IM) or Coronavirus Disease 2019 (Covid-19)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ME/CFS
CFS/ME
ME/CFS Following EBV-associated Infectious Mononucleosis
ME/CFS Following COVID-19
Keywords: ME/CFS
CFS/ME
SARS-CoV-2
COVID-10
Post-COVID-19 condition
Chronic fatigue syndrome
Myalgic encephalomyelitis
Epstein-Barr virus
EBV
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2023-03-21
Enrollment: 650
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ME/CFS

Brief summary: The ME/CFS study (MECFS-R) aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for ME/CFS at any age in Germany, which can be used for future clinical trials.

Detailed description: ME/CFS (ICD-10 G93.3) is a multisystem chronic disease that can lead to severe disability. Pre-pandemic prevalence was estimated at approximately 0.3% worldwide, and increasing prevalence is observed due to ME/CFS in the context of long-term sequelae of coronavirus diseases 2019 (COVID-19). In Germany, the number of affected people in Germany was estimated as approximately 350.000-400.000 in 2018/2019 and almost 500.000 in 2021. ME/CFS can manifest at any age, with peak prevalence in adolescents and young adults. Common triggers include COVID, influenza, and Epstein-Barr virus-associated infectious mononucleosis (EBV-IM). Non-infectious triggers are known as well. Autoimmunity and dysfunction of the autonomic nervous system (ANS) were suggested as possible pathomechanisms. Core symptoms include fatigue, post-exertional malaise (PEM), and unrefreshing sleep. Additional symptoms comprise cognitive deficits ("brain fog"), orthostatic intolerance, neuroendocrine, and immunological symptoms. ME/CFS is diagnosed according to clinical criteria (mostly criteria by the Institute of Medicine (IOM) or Canadian Consensus Criteria) and by appropriate differential diagnostics to exclude other disorders with similar symptoms. So far, no biomarker or specific therapy is available. Therapeutic approaches are holistic and aim at the palliation of symptoms as well as psychosocial support. Self-management with pacing is recommended. Knowledge of ME/CFS among healthcare providers is still scarce, and many patients do not receive adequate care.

With this web-based, German-wide registry, the investigators aim at deep phenotyping of the disease, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. Patients are also invited to contribute biosamples for future translational research.

Eligibility criteria: Inclusion Criteria:

* ME/CFS diagnosis (ICD-10 G93.3) based on internationally established criteria
* Informed consent by patients and/or guardian(s)

Exclusion Criteria:

* No ME/CFS (ICD-10 G93.3)
* No informed consent

Primary outcomes:
measure: Phenotyping ME/CFS: Medical History
timeFrame: 30 years
measure: Assessment of routine physical examination findings
timeFrame: 30 years
measure: Number of participants with abnormal laboratory tests results
timeFrame: 30 years
measure: Number of participants with abnormal technical exam results
timeFrame: 30 years
Secondary outcomes:
measure: Evaluation of Patient Journeys
timeFrame: 30 years
measure: Definition of Sub-cohorts
timeFrame: 30 years
measure: Prevalence of Comorbidities
timeFrame: 30 years
measure: Identification of Candidate Prognostic Markers
timeFrame: 30 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
state: Bavaria
Study officials:
affiliation: MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
name: Uta Behrends, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: