Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT06653712
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-22
First Post:
2024-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-20', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-20', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Personal data', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Name, date of birth, contact details'}, {'measure': 'Clinical data', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports'}, {'measure': 'Physical assessment', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Heart rate', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'beats per minute'}, {'measure': 'Blood pressure', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'in mmHg'}, {'measure': 'Questionnaire data', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31'}, {'measure': 'YSR questionnaire', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Open questions and questions to be rated on a scale'}, {'measure': 'Imaging', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'OCT-A: Imaging of ocular fundus'}, {'measure': 'Full blood count', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'CRP, Ferritin, Creatinin, GPT and Immunglobuline'}, {'measure': 'Deformability Cytometer', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Cell-deformation'}, {'measure': 'Virology', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies'}, {'measure': 'Immunology', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'ANA, Cystatin C, dsDNA Ak'}, {'measure': 'Endocrinology', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'TPO antibodies'}, {'measure': 'B-cell phenotyping', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Analysis of surface antigens using cytometry by time of flights (CyTOF)'}, {'measure': 'Pain threshold', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates'}, {'measure': 'Orthostasic Tolerance', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance'}, {'measure': 'Grip strength', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Hand dynamometer test to assess grip strength in Newton'}, {'measure': 'Smell test', 'timeFrame': 'Measurement is taken at a single time point right after enrollment', 'description': 'Recognition of different substances'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ME/CFS', 'Post-Covid', 'Biomarker'], 'conditions': ['Healthy Controls']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy controls are recruited via public relations', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure)\n* Age: 10 - 25 years\n* Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives\n\nExclusion Criteria:\n\n* Acute illnesses (e.g. infections) or major injuries\n* Known chronic diseases (including psychological diagnoses) other than those mentioned above\n* Surgery or blood transfusion in the last 3 months\n* No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination\n* Pregnancy; Breastfeeding\n* Limited legal capacity'}, 'identificationModule': {'nctId': 'NCT06653712', 'acronym': 'HelP', 'briefTitle': 'Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Healthy Control Population für PAIS-ME/CFS: Studie Zur Evaluation möglicher Biomarker Und Untersuchungsmethoden für Die PAIS-ME/CFS-Diagnostik Bei Gesunden Probanden', 'orgStudyIdInfo': {'id': 'HelP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy controls', 'description': 'Healthy participants between 10 and 25 years of age. We plan to recruit 5 to 10 participants per age group.', 'interventionNames': ['Diagnostic Test: Diagnostic Test']}], 'interventions': [{'name': 'Diagnostic Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The following clinical data sources are used:\n\n* Personal interview (anamnesis)\n* Physical examination\n* Questionnaires\n* Functional assessment\n* Imaging techniques\n\nThe following biological materials are used:\n\n• Max. 30 ml of blood', 'armGroupLabels': ['Healthy controls']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Prof. Dr. med. Uta Behrends', 'role': 'CONTACT', 'email': 'uta.behrends@mri.tum.de', 'phone': '+49 89 3068 2793'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Max-Planck Institut', 'class': 'UNKNOWN'}, {'name': 'University Hospital Erlangen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}