Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 3:38 AM
Study NCT ID:
NCT04048993
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry-based Biobank Development and Integrative Physiological Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Muscle biopsies, fat biopsies, microdialysate, urine, plasma, blood, dried blood spots'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biobank creation', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Collection of biological samples from subjects included in the Section Registry'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Integrative Human Physiology']}, 'descriptionModule': {'briefSummary': 'The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Human subjects able to perform exercise', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to perform fatiguing exercise\n\nExclusion Criteria:\n\n* severe mental or physical handicap\n* chronic disease deemed by the M.D. to preclude inclusion\n* use of prescription medicine deemed by the M.D. to preclude inclusion'}, 'identificationModule': {'nctId': 'NCT04048993', 'briefTitle': 'Registry-based Biobank Development and Integrative Physiological Analysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Registry-based Biobank Development and Integrative Physiological Analysis', 'orgStudyIdInfo': {'id': 'BIO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biobank development and integrative physiological analysis', 'type': 'OTHER', 'description': 'Collection of biological samples (blood, urine, interstitial fluid, adipose tissue and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Hostrup, PhD', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '24474785'}], 'facility': 'University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Morten Hostrup, PhD', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '24474785'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}