ME/CFSMECFS-RNCT05778006
Multi-Center Registry for ME/CFS
An observational study of ME/CFS and CFS/ME, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- ME/CFS, CFS/ME, ME/CFS Following EBV-associated Infectious Mononucleosis
- How many people
- 650 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2022to 31 May 2052
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ME/CFS
Who may be able to join
- ME/CFS diagnosis (ICD-10 G93.3) based on internationally established criteria
- Informed consent by patients and/or guardian(s)
Who cannot join
- No ME/CFS (ICD-10 G93.3)
- No informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniela Schindler, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
Munich, Bavaria, 80804
Uta Behrends, Prof., +89 30682632, register.mcfc@mri.tum.de
About this study
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)
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.
Read the 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.
- 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
- Medical subject headings
- Fatigue Syndrome, Chronic, Epstein-Barr Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotyping ME/CFS: Medical History
Routine assessment of the medical history, such as current and previous medication, vaccinations, comorbidities, and more, to achieve a profound ME/CFS phenotype.
Measured: 30 years
Assessment of routine physical examination findings
Routine physical examination to achieve a profound and detailed ME/CFS phenotype.
Measured: 30 years
Number of participants with abnormal laboratory tests results
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.
Measured: 30 years
Number of participants with abnormal technical exam results
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.
Measured: 30 years
Secondary outcomes (4)
Evaluation of Patient Journeys
Patients' journeys will be analyzed regarding the specialization of involved physicians visited, time to diagnosis, and time to treatment.
Measured: 30 years
Definition of Sub-cohorts
Using routine data, sub-cohorts will be identified.
Measured: 30 years
Prevalence of Comorbidities
Prevalence of comorbidities of patients with ME/CFS will be analyzed.
Measured: 30 years
Identification of Candidate Prognostic Markers
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).
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start31 May 2022
- Primary completion31 May 2052 (estimated)
- Study completion31 May 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ME/CFSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Uta Behrends, Prof. Dr. med., Principal investigator, MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778006
- Sponsor's protocol ID
- MECFS-R
- Acronym
- MECFS-R
- Status last verified
- Jan 2025
- First submitted
- 20 Mar 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hieber H, Pricoco R, Gerrer K, Heindrich C, Wiehler K, Mihatsch LL, Haegele M, Schindler D, Donath Q, Christa C, Grabbe A, Kircher A, Leone A, Mueller Y, Zietemann H, Freitag H, Sotzny F, Warlitz C, Stojanov S, Hattesohl DBR, Hausruckinger A, Mittelstrass K, Scheibenbogen C, Behrends U. The German Multicenter Registry for ME/CFS (MECFS-R). J Clin Med. 2024 May 28;13(11):3168. doi: 10.3390/jcm13113168.
PubMed 38892879
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05778006
- Acronym / sponsor ID
- MECFS-R / MECFS-R
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 May 2052 (estimated)
- Study completion
- 31 May 2052 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ME/CFS
Key inclusion criteria (2 listed)
- ME/CFS diagnosis (ICD-10 G93.3) based on internationally established criteria
- Informed consent by patients and/or guardian(s)
Key exclusion criteria (2 listed)
- No ME/CFS (ICD-10 G93.3)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Assessment of routine physical examination findings
Time frame: 30 years
Routine physical examination to achieve a profound and detailed ME/CFS phenotype.
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.
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.
4 secondary outcomes
Evaluation of Patient Journeys
Time frame: 30 years
Definition of Sub-cohorts
Time frame: 30 years
Prevalence of Comorbidities
Time frame: 30 years
Identification of Candidate Prognostic Markers
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 38892879Hieber H, Pricoco R, Gerrer K, Heindrich C, Wiehler K, Mihatsch LL, Haegele M, Schindler D, Donath Q, Christa C, Grabbe A, Kircher A, Leone A, Mueller Y, Zietemann H, Freitag H, Sotzny F, Warlitz C, Stojanov S, Hattesohl DBR, Hausruckinger A, Mittelstrass K, Scheibenbogen C, Behrends U. The German Multicenter Registry for ME/CFS (MECFS-R). J Clin Med. 2024 May 28;13(11):3168. doi: 10.3390/jcm13113168.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Schindler, Dr. contact
Uta Behrends, Prof. Dr. med. principal investigator
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ME/CFS and CFS/ME, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uta Behrends, Prof. Dr. med. (+4989 30682632, uta.behrends@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotyping ME/CFS: Medical History (time frame: 30 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.