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

NCT06653712 | Not Yet Recruiting

• 1 other identifier: HelP
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Controls

Keywords

ME/CFS; Post-Covid; Biomarker

Outcome Measures

Primary Outcomes (18)

• Personal data

  Name, date of birth, contact details

  Measurement is taken at a single time point right after enrollment

• Clinical data

  Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports

  Measurement is taken at a single time point right after enrollment

• Physical assessment

  weight and height will be combined to report BMI in kg/m\^2

  Measurement is taken at a single time point right after enrollment

• Heart rate

  beats per minute

  Measurement is taken at a single time point right after enrollment

• Blood pressure

  in mmHg

  Measurement is taken at a single time point right after enrollment

• Questionnaire data

  Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31

  Measurement is taken at a single time point right after enrollment

• YSR questionnaire

  Open questions and questions to be rated on a scale

  Measurement is taken at a single time point right after enrollment

• Imaging

  OCT-A: Imaging of ocular fundus

  Measurement is taken at a single time point right after enrollment

• Full blood count

  CRP, Ferritin, Creatinin, GPT and Immunglobuline

  Measurement is taken at a single time point right after enrollment

• Deformability Cytometer

  Cell-deformation

  Measurement is taken at a single time point right after enrollment

• Virology

  EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies

  Measurement is taken at a single time point right after enrollment

• Immunology

  ANA, Cystatin C, dsDNA Ak

  Measurement is taken at a single time point right after enrollment

• Endocrinology

  TPO antibodies

  Measurement is taken at a single time point right after enrollment

• B-cell phenotyping

  Analysis of surface antigens using cytometry by time of flights (CyTOF)

  Measurement is taken at a single time point right after enrollment

• Pain threshold

  Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates

  Measurement is taken at a single time point right after enrollment

• Orthostasic Tolerance

  blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance

  Measurement is taken at a single time point right after enrollment

• Grip strength

  Hand dynamometer test to assess grip strength in Newton

  Measurement is taken at a single time point right after enrollment

• Smell test

  Recognition of different substances

  Measurement is taken at a single time point right after enrollment

Study Arms (1)

Healthy controls

Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group.

Diagnostic Test: Diagnostic Test

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

Healthy controls

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls are recruited via public relations

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Charite University, Berlin, Germany: collaborator
• Max-Planck Institut: collaborator
• University Hospital Erlangen: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Prof. Dr. med. Uta Behrends

CONTACT

+49 89 3068 2793; uta.behrends@mri.tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 22, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 22, 2024

Record last verified: 2024-09