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Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS)

About

Status:
Ongoing
Principal investigator:
Country:
Germany
Study start:
2019-01-21
Completion (planned):
2028-12-31
Last update:
2023-11-30

 

Research types:
Epidemiological research
Research areas:
General
Interventions:
Not applicable
Priv. Sector Partner:
Not available
Sponsors:

Project description

The Munich Cohort Study With Biobank for Children, Adolescents, and Young Adults With Post-infection ME/CFS (MUC-CFS) cohort study aims to collect comprehensive clinical data regarding medical history, clinical and laboratory phenotypes, the trajectory of individual diseases, health-related quality of life, education, and social participation. Clinical data are derived from complex initial investigations at in- or out-patient visits as well as from following telephone calls and from various questionnaires. Biosampling (blood, urine, and/or mouthwashes) takes place at any personal visit for later cell-analytical, molecular, and/or biochemical analyses by our study group.

The MUC-CFS cohort study is recruiting patients from the MRI Chronic Fatigue Center for Young People (MCFC) at the Technical University of Munich (TUM) and the Munich Municipal Hospital (MüK) in Munich, Germany. The MCFC closely cooperates with the Charité Fatigue Center (CFC) in Berlin, Germany, and has long-standing expertise in ME/CFS care and research.

The estimated number of enrolled patients is 200. The final number of study participants will not be limited. Outcome measures at 5 years of project duration include:

A) Extensive Phenotyping of ME/CFS Patients Extensive phenotyping of children, adolescent, and young adult patients with post-infectious ME/CFS (e.g., age, gender, medical history, daily function, health-related quality of life, severity and frequency of symptoms, disease trajectory over time).

B) Identification of risk factors for protracted courses without (partial) remission (e.g., age at symptom onset, sex, sociodemographic variables, medical history, medication, daily function at symptom onset, severity and frequency of symptoms at symptom onset, laboratory values, EBV serology, EBV DNA load).

C) Identification of diagnostic biomarkers, i.e., a single and/or a combination of which, indicative of post-infectious ME/CFS (e.g., inflammatory markers, autoantibodies, EBV serology, EBV DNA load).

(Description adapted from clinical trial website: see link above)

Patient cohort

Post-infectious ME/CFS according to Institute of Medicine (IOM), Canadian Consensus Criteria (CCC), the diagnostic worksheet published by Rowe et al. (2017), or the pediatric case definition published by Jason et al. (2006).

Patients enrolled: 200

Age group: 0 - 25 years (Children, Adults)

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