Multi-Center Registry for ME/CFS
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: ME/CFS, CFS/ME, ME/CFS Following EBV-associated Infectious Mononucleosis, ME/CFS Following COVID-19. Базовые параметры: от 0 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Multi-Center Registry for ME/CFS, Including ME/CFS Following Epstein-Barr Virus-Associated Infectious Mononucleosis (EBV-IM) or Coronavirus Disease 2019 (Covid-19)
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Phenotyping ME/CFS: Medical History [Срок оценки: 30 years]
- Assessment of routine physical examination findings [Срок оценки: 30 years]
- Number of participants with abnormal laboratory tests results [Срок оценки: 30 years]
- Number of participants with abnormal technical exam results [Срок оценки: 30 years]
Вторичные конечные точки (4)
- Evaluation of Patient Journeys [Срок оценки: 30 years]
- Definition of Sub-cohorts [Срок оценки: 30 years]
- Prevalence of Comorbidities [Срок оценки: 30 years]
- Identification of Candidate Prognostic Markers [Срок оценки: 30 years]
Критерии участия
Критерии включения
- ME/CFS diagnosis (ICD-10 G93.3) based on internationally established criteria
- Informed consent by patients and/or guardian(s)
Критерии исключения
- No ME/CFS (ICD-10 G93.3)
- No informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical Universi — Munich
Публикации
- 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/jcm13113 PMID 38892879
Идентификаторы
NCT: NCT05778006 · MECFS-R