Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-02 @ 10:14 AM
Study NCT ID:
NCT07132333
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Inflammation Board at the Center for Personalized Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '14 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapy persistence', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Duration of intervention with biological agent'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic inflammatory diseases', 'personalized medicine'], 'conditions': ['Psoriasis (PsO)', 'Psoriasis Arthritis', 'Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)', 'Spondylarthropathies']}, 'descriptionModule': {'briefSummary': 'Molecular Inflammation Board at the Center for Personalized Medicine', 'detailedDescription': 'Molecular Inflammation Board at the Center for Personalized Medicine\n\nThe study objectives are:\n\nTo ensure a prospective documentation of all patients who are referred to the Molecular Inflammation Board in routine clinical care To prospectively ensure the documentation of MEB patients with an emphasis to clinical outcome parameters and further response assessments (e.g. peripheral immunmonitoring, imaging parameters) To prospectively assess patient-reported outcome of MEB patients To evaluate compliance to MEB suggestions in routine clinical care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic inflammatory diseases and indication for therapy with biologic agents', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic inflammatory disorder (PsO, PsA, SpA, IBD)\n* Given informed consent\n* 18 years of age\n\nExclusion Criteria:\n\n* No capacity to consent'}, 'identificationModule': {'nctId': 'NCT07132333', 'acronym': 'MEB@ZPM', 'briefTitle': 'Molecular Inflammation Board at the Center for Personalized Medicine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'The Molecular Inflammation Board at the Centers for Personalized Medicine at the University Hospitals of Freiburg, Heidelberg, Tübingen and Ulm - A Multicenter Prospective Observational Study', 'orgStudyIdInfo': {'id': '482/2022BO1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biologic Agent', 'type': 'BIOLOGICAL', 'description': 'Intervention with biologic agents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fee Schmitt, Dr.', 'role': 'CONTACT', 'email': 'zpm-meb@med.uni-tuebingen.de', 'phone': '+4970712981240'}], 'facility': 'University Hospital of Tübingen - Center for Personalized Medicine', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Nisar P Malek, Prof. Dr.', 'role': 'CONTACT', 'email': 'zpm-meb@med.uni-tuebingen.de', 'phone': '+4970712982722'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'University Hospital Ulm', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}