Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:50 AM
Study NCT ID:
NCT04753593
Status:
RECRUITING
Last Update Posted:
2023-02-10
First Post:
2021-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061205', 'term': 'Vascular Calcification'}], 'ancestors': [{'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'discarded human tissue fragments : vessel and bone tissue that are been harvested during surgery and which are not intended to be used for clinical-biological management of patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success in establishment of Cell Culture Systems from discarded surgery specimens', 'timeFrame': '5 years', 'description': 'Success in establishment of Cell Culture Systems from discarded surgery specimens'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoblast', 'Vascular Calcification', 'vascular smooth muscle cell', 'Cardiac valve calcification', 'Valvular interstitial cell', 'bone tissue'], 'conditions': ['Osteoblast', 'Vascular Calcification']}, 'descriptionModule': {'briefSummary': 'Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The aortic wall and aortic valve discarded specimens will come from the Cardiac Surgery department of Amiens Picardie CHU. The bone and peri-bone discarded specimens will come from the orthopedic surgery services of the CHU Amiens-Picardie.\n\nThe collection of samples and their use is part of various projects carried out by research project leaders supported by the laboratory MP3CV (CURS, site CHU sud, Amiens). No genomic analysis is planned for these samples. None clinical data is associated with the interpretation of data collected through the work that will be carried out from these human tissue samples. There are no collections per se, the samples collected are pseudonymized.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgery in the Cardiac Surgery and Orthopedic Surgery departments of the CHU Amiens-Picardie\n* patients who will be beforehand informed\n* patients who will not be opposed to this study.\n\nExclusion Criteria:\n\n* HIV and hepatitis positive patients'}, 'identificationModule': {'nctId': 'NCT04753593', 'acronym': 'HumTisRes', 'briefTitle': 'Use of Discarded Surgery Human Tissue Specimens for Basic Science Research', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Use of Discarded Surgery Human Tissue Specimens for Basic Science Research', 'orgStudyIdInfo': {'id': 'PI2021_843_0002'}}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romual Mentaverri, Pr', 'role': 'CONTACT', 'email': 'romuald.mentaverri@u-picardie.fr', 'phone': '03 22 887104'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Romuald Mentaverri, Pr', 'role': 'CONTACT', 'email': 'romuald.mentaverri@u-picardie.fr', 'phone': '03 22 887104'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}