Healthy Control Population für PAIS-ME/CFS: Studie Zur Evaluation möglicher Biomarker Und Untersuchungsmethoden für Die PAIS-ME/CFS-Diagnostik Bei Gesunden Probanden
| Registry | NCT06653712, acronym HelP |
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| Status | Not yet recruiting |
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| Study type | Observational |
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| Enrollment | 200 (Estimated) |
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| Sponsor | Technical University of Munich (Other); collaborators: Charite University, Berlin, Germany, Max-Planck Institut, University Hospital Erlangen |
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| Conditions | Healthy Controls |
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| Interventions | Diagnostic Test (Diagnostic test) |
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| Dates | start 2024-10-01 (estimated), primary completion 2029-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2024-10-22, last updated 2024-10-22 |
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-Summary
Using the data from the HelP study, the underlying processes of the diseases ME/CFS and PAIS are to be researched and elucidated. The comparison of affected patients with healthy controls is intended to identify disease-specific patterns that could be related to the development or progression of the disease. The aim is to find a suitable biomarker for diagnostics and to develop therapeutic approaches.
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+Detailed description
The underlying pathomechanisms of the diseases PAIS and ME/CFS are to be investigated and elucidated in more detail. The aim is to establish a cohort of healthy controls at our MRI Chronic Fatigue Center (MCFC). Within this cohort, the measurement instruments used so far in ME/CFS diagnostics will be validated. In addition, data material from this pool should be used for the statistical evaluations of various case-control studies of our center and our cooperation partners in order to find and develop a suitable biomarker for diagnostics and therapeutic approaches for PAIS and ME/CFS.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Healthy controls | | Diagnostic Test: Diagnostic Test | Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group. |
- Diagnostic Test (Diagnostic test): The following clinical data sources are used:
* Personal interview (anamnesis)
* Physical examination
* Questionnaires
* Functional assessment
* Imaging techniques
The following biological materials are used:
• Max. 30 ml of blood
+Outcome measures
Primary outcomes
- Personal data [Measurement is taken at a single time point right after enrollment]: Name, date of birth, contact details
- Clinical data [Measurement is taken at a single time point right after enrollment]: Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports
- Physical assessment [Measurement is taken at a single time point right after enrollment]: weight and height will be combined to report BMI in kg/m\^2
- Heart rate [Measurement is taken at a single time point right after enrollment]: beats per minute
- Blood pressure [Measurement is taken at a single time point right after enrollment]: in mmHg
- Questionnaire data [Measurement is taken at a single time point right after enrollment]: Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31
- YSR questionnaire [Measurement is taken at a single time point right after enrollment]: Open questions and questions to be rated on a scale
- Imaging [Measurement is taken at a single time point right after enrollment]: OCT-A: Imaging of ocular fundus
- Full blood count [Measurement is taken at a single time point right after enrollment]: CRP, Ferritin, Creatinin, GPT and Immunglobuline
- Deformability Cytometer [Measurement is taken at a single time point right after enrollment]: Cell-deformation
- Virology [Measurement is taken at a single time point right after enrollment]: EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies
- Immunology [Measurement is taken at a single time point right after enrollment]: ANA, Cystatin C, dsDNA Ak
- Endocrinology [Measurement is taken at a single time point right after enrollment]: TPO antibodies
- B-cell phenotyping [Measurement is taken at a single time point right after enrollment]: Analysis of surface antigens using cytometry by time of flights (CyTOF)
- Pain threshold [Measurement is taken at a single time point right after enrollment]: Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates
- Orthostasic Tolerance [Measurement is taken at a single time point right after enrollment]: blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance
- Grip strength [Measurement is taken at a single time point right after enrollment]: Hand dynamometer test to assess grip strength in Newton
- Smell test [Measurement is taken at a single time point right after enrollment]: Recognition of different substances
+Eligibility
Sex: All, ages: 10 Years to 25 Years, accepts healthy volunteers
Inclusion Criteria:
* Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure)
* Age: 10 - 25 years
* Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives
Exclusion Criteria:
* Acute illnesses (e.g. infections) or major injuries
* Known chronic diseases (including psychological diagnoses) other than those mentioned above
* Surgery or blood transfusion in the last 3 months
* No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination
* Pregnancy; Breastfeeding
* Limited legal capacity