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Not yet recruiting NCT06653712

Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers

— Observational Healthy Controls

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnostic Test.
Who it may be relevant to
Registry conditions: Healthy Controls. Basic parameters: 10 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Healthy Control Population für PAIS-ME/CFS: Studie Zur Evaluation möglicher Biomarker Und Untersuchungsmethoden für Die PAIS-ME/CFS-Diagnostik Bei Gesunden Probanden

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Personal data [Time frame: Measurement is taken at a single time point right after enrollment]
  • Clinical data [Time frame: Measurement is taken at a single time point right after enrollment]
  • Physical assessment [Time frame: Measurement is taken at a single time point right after enrollment]
  • Heart rate [Time frame: Measurement is taken at a single time point right after enrollment]
  • Blood pressure [Time frame: Measurement is taken at a single time point right after enrollment]
  • Questionnaire data [Time frame: Measurement is taken at a single time point right after enrollment]
  • YSR questionnaire [Time frame: Measurement is taken at a single time point right after enrollment]
  • Imaging [Time frame: Measurement is taken at a single time point right after enrollment]
  • Full blood count [Time frame: Measurement is taken at a single time point right after enrollment]
  • Deformability Cytometer [Time frame: Measurement is taken at a single time point right after enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06653712 · HelP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗