Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-11 @ 5:35 AM
Study NCT ID:
NCT02368769
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2015-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Tele-expertise for Frozen Section Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-02-15', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon', 'timeFrame': '30 minutes after the sample extraction'}], 'secondaryOutcomes': [{'measure': 'Delay between extraction of the sample and the diagnosis given to the surgeon', 'timeFrame': '24h after procedure'}, {'measure': 'Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis', 'timeFrame': 'Once a month'}, {'measure': 'Overall cost of a frozen section diagnosis', 'timeFrame': '6 months after the first patient enrollment', 'description': 'Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Frozen Sections']}, 'referencesModule': {'references': [{'pmid': '22297471', 'type': 'BACKGROUND', 'citation': 'Gould PV, Saikali S. A comparison of digitized frozen section and smear preparations for intraoperative neurotelepathology. Anal Cell Pathol (Amst). 2012;35(2):85-91. doi: 10.3233/ACP-2011-0026.'}, {'pmid': '22233700', 'type': 'BACKGROUND', 'citation': 'Tetu B, Fortin JP, Gagnon MP, Louahlia S. The challenges of implementing a "patient-oriented" telepathology network; the Eastern Quebec telepathology project experience. Anal Cell Pathol (Amst). 2012;35(1):11-8. doi: 10.3233/ACP-2011-0023.'}, {'pmid': '26857558', 'type': 'DERIVED', 'citation': 'Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.'}], 'seeAlsoLinks': [{'url': 'http://www.renewinghealth.eu/assessment-method', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who need a frozen section diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02368769', 'acronym': 'Télé-extempo', 'briefTitle': 'Assessment of Tele-expertise for Frozen Section Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis', 'orgStudyIdInfo': {'id': 'TLM-Pathology Frozen Section'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'During tele-expertise', 'description': 'Remote site interpretation of frozen section', 'interventionNames': ['Device: During Tele-expertise']}, {'label': 'Before tele-expertise', 'description': 'Usual (on site) frozen section'}], 'interventions': [{'name': 'During Tele-expertise', 'type': 'DEVICE', 'armGroupLabels': ['During tele-expertise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': "Service d'Anatomie pathologique. Hôpital Antoine Béclère", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': "Service d'anatomie pathologique. Hôpital Bicêtre", 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': "Service d'anatomie pathologique. Hôpital de Raincy-Montfermeil", 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': "Service d'ORL. Hôpital du Raincy-Montfermeil", 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': "Service d'anatomie pathologique. Hôpital Saint Antoine", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Service de chirurgie viscérale. Hôpital des Diaconnesses', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Catherine Guettier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Bicêtre. Assistance Publique - Hôpitaux de Paris'}, {'name': 'Isabelle Durand-Zaleski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRCD URC Eco. Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Agence Regionale de Sante d'Ile de France", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}