Multi-Center Registry for ME/CFS

Recruiting

• Conditions: CFS/ME; ME/CFS Following EBV-associated Infectious Mononucleosis; ME/CFS Following COVID-19; ME/CFS

• Registration Number: NCT05778006
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2052-05-31
• Study Completion: 2052-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal laboratory tests results	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.
Phenotyping ME/CFS: Medical History	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.
Assessment of routine physical examination findings	30 years	Routine physical examination to achieve a profound and detailed ME/CFS phenotype.
Number of participants with abnormal technical exam results	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 Outcome Measures

Name	Time	Method
Prevalence of Comorbidities	30 years	Prevalence of comorbidities of patients with ME/CFS will be analyzed.
Evaluation of Patient Journeys	30 years	Patients' journeys will be analyzed regarding the specialization of involved physicians visited, time to diagnosis, and time to treatment.
Definition of Sub-cohorts	30 years	Using routine data, sub-cohorts will be identified.
Identification of Candidate Prognostic Markers	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).

Trial Locations

Locations (1)

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