Healthy ControlsHelPNCT06653712
Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers
An observational study of Healthy Controls, run by Technical University of Munich.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- Diagnostic Test
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy controls are recruited via public relations
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Controls
- Being tested
- Diagnostic Test
- Keywords
- ME/CFS, Post-Covid, Biomarker
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group. Receives: Diagnostic Test: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal data
Name, date of birth, contact details
Measured: 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
Measured: 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
Measured: Measurement is taken at a single time point right after enrollment
Heart rate
beats per minute
Measured: Measurement is taken at a single time point right after enrollment
Blood pressure
in mmHg
Measured: 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
Measured: Measurement is taken at a single time point right after enrollment
YSR questionnaire
Open questions and questions to be rated on a scale
Measured: Measurement is taken at a single time point right after enrollment
Imaging
OCT-A: Imaging of ocular fundus
Measured: Measurement is taken at a single time point right after enrollment
Full blood count
CRP, Ferritin, Creatinin, GPT and Immunglobuline
Measured: Measurement is taken at a single time point right after enrollment
Deformability Cytometer
Cell-deformation
Measured: Measurement is taken at a single time point right after enrollment
Virology
EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies
Measured: Measurement is taken at a single time point right after enrollment
Immunology
ANA, Cystatin C, dsDNA Ak
Measured: Measurement is taken at a single time point right after enrollment
Endocrinology
TPO antibodies
Measured: 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)
Measured: 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
Measured: 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
Measured: Measurement is taken at a single time point right after enrollment
Grip strength
Hand dynamometer test to assess grip strength in Newton
Measured: Measurement is taken at a single time point right after enrollment
Smell test
Recognition of different substances
Measured: Measurement is taken at a single time point right after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Max-Planck Institut, University Hospital Erlangen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653712
- Sponsor's protocol ID
- HelP
- Acronym
- HelP
- Status last verified
- Sep 2024
- First submitted
- 4 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06653712
- Acronym / sponsor ID
- HelP / HelP
- Conditions
- Healthy Controls
- Keywords
- ME/CFS, Post-Covid, Biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Max-Planck Institut, University Hospital Erlangen
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Diagnostic TestHealthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy controls are recruited via public relations
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestThe 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 | Diagnostic test | Healthy controls |
Primary outcome
Personal data
Time frame: Measurement is taken at a single time point right after enrollment
Name, date of birth, contact details
Clinical data
Time frame: 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
Time frame: 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
Time frame: Measurement is taken at a single time point right after enrollment
beats per minute
Blood pressure
Time frame: Measurement is taken at a single time point right after enrollment
in mmHg
Questionnaire data
Time frame: 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
Time frame: Measurement is taken at a single time point right after enrollment
Open questions and questions to be rated on a scale
Imaging
Time frame: Measurement is taken at a single time point right after enrollment
OCT-A: Imaging of ocular fundus
Full blood count
Time frame: Measurement is taken at a single time point right after enrollment
CRP, Ferritin, Creatinin, GPT and Immunglobuline
Deformability Cytometer
Time frame: Measurement is taken at a single time point right after enrollment
Cell-deformation
Virology
Time frame: Measurement is taken at a single time point right after enrollment
EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies
Immunology
Time frame: Measurement is taken at a single time point right after enrollment
ANA, Cystatin C, dsDNA Ak
Endocrinology
Time frame: Measurement is taken at a single time point right after enrollment
TPO antibodies
B-cell phenotyping
Time frame: Measurement is taken at a single time point right after enrollment
Analysis of surface antigens using cytometry by time of flights (CyTOF)
Pain threshold
Time frame: 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
Time frame: 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
Time frame: Measurement is taken at a single time point right after enrollment
Hand dynamometer test to assess grip strength in Newton
Smell test
Time frame: Measurement is taken at a single time point right after enrollment
Recognition of different substances
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Controls, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. med. Uta Behrends (+49 89 3068 2793, uta.behrends@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal data (time frame: Measurement is taken at a single time point right after enrollment). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.