Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05778006

Multi-Center Registry for ME/CFS

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

ME/CFS CFS/ME Chronic Disease DNA Virus Infections Disease Attributes Encephalomyelitis Epstein-Barr Virus Infections Fatigue Syndrome, Chronic Herpesviridae Infections Infections ME/CFS Following COVID-19 ME/CFS Following EBV-associated Infectious Mononucleosis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Infections Virus Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital

Munich, Bavaria, 80804, Germany

Location status: Recruiting

Location contact

Uta Behrends, Prof.

CONTACT

[email protected]

+89 30682632

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Phenotyping ME/CFS: Medical History

    Time frame: 30 years

    Routine assessment of the medical history, such as current and previous medication, vaccinations, comorbidities, and more, to achieve a profound ME/CFS phenotype.

  2. Assessment of routine physical examination findings

    Time frame: 30 years

    Routine physical examination to achieve a profound and detailed ME/CFS phenotype.

  3. Number of participants with abnormal laboratory tests results

    Time frame: 30 years

    Measurement of a routine set of laboratory parameters including blood tests (cell count[cell/µl], C-reactive protein [mg/dl], immunoglobulins A/M/G [md/dl], antinuclear antibodies [titer], etc.) and urine/stool analysis (e.g. calprotectin [mg/kg], positive hemoglobin in urine test stripe) to achieve a profound ME/CFS phenotype.

  4. Number of participants with abnormal technical exam results

    Time frame: 30 years

    Technical exams (e.g. restrictive and obstructive pattern in pulmonary function tests, conduction in electrocardiography, ultrasound imaging, magnetic resonance imaging, etc.) will be performed as indicated to achieve a profound and detailed ME/CFS phenotype.

Secondary outcomes

  1. Evaluation of Patient Journeys

    Time frame: 30 years

    Patients' journeys will be analyzed regarding the specialization of involved physicians visited, time to diagnosis, and time to treatment.

  2. Definition of Sub-cohorts

    Time frame: 30 years

    Using routine data, sub-cohorts will be identified.

  3. Prevalence of Comorbidities

    Time frame: 30 years

    Prevalence of comorbidities of patients with ME/CFS will be analyzed.

  4. Identification of Candidate Prognostic Markers

    Time frame: 30 years

    Correlation of routine clinical data (e.g., medical history, routine laboratory, and physical examination) with clinical outcome (e.g., health-related quality of life, disease severity, and social participation).

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Schindler, Dr.

CONTACT

+4989 41406995

Uta Behrends, Prof. Dr. med.

CONTACT

[email protected]

+4989 30682632

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study 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)

Acronym: MECFS-R

Important dates

Study start
2022
Primary completion
2052
Study completion
2052
First posted
Mar 21, 2023
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.