NCT05778006

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
317mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
May 2022May 2052

Study Start

First participant enrolled

May 31, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
29.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2052

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2052

Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

30 years

First QC Date

March 20, 2023

Last Update Submit

January 8, 2025

Conditions

ME/CFSCFS/MEME/CFS Following EBV-associated Infectious MononucleosisME/CFS Following COVID-19

Keywords

ME/CFSCFS/MESARS-CoV-2COVID-10Post-COVID-19 conditionChronic fatigue syndromeMyalgic encephalomyelitisEpstein-Barr virusEBV

Outcome Measures

Primary Outcomes (4)

  • 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.

    30 years

  • Assessment of routine physical examination findings

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

    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.

    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.

    30 years

Secondary Outcomes (4)

  • Evaluation of Patient Journeys

    30 years

  • Definition of Sub-cohorts

    30 years

  • Prevalence of Comorbidities

    30 years

  • Identification of Candidate Prognostic Markers

    30 years

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ME/CFS

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 80804, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38892879DERIVED

Biospecimen

Retention: NONE RETAINED

Serum samples.

MeSH Terms

Conditions

Fatigue Syndrome, ChronicEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Uta Behrends, Prof. Dr. med.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Uta Behrends, Prof. Dr. med.

CONTACT

+4989 30682632uta.behrends@tum.de

Daniela Schindler, Dr.

CONTACT

+4989 41406995

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 21, 2023

Study Start

May 31, 2022

Primary Completion (Estimated)

May 31, 2052

Study Completion (Estimated)

May 31, 2052

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

DE(1)