Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT03558932
Status:
UNKNOWN
Last Update Posted:
2018-06-15
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IP3R Modulation by Cancer Genes in Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'pleural biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunoblotting', 'timeFrame': '5 years', 'description': 'biopsy'}, {'measure': 'Cytometric analysis (FACS-based approaches)', 'timeFrame': '5 years', 'description': 'biopsy'}, {'measure': 'Live cell imaging for Ca2+-signaling', 'timeFrame': '5 years', 'description': 'biopsy'}], 'primaryOutcomes': [{'measure': 'Pleural biopsy', 'timeFrame': '5 years', 'description': 'Biopsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Mesothelioma']}, 'descriptionModule': {'briefSummary': 'Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'mesothelioma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspicion of mesothelioma\n* referral for diagnostic thoracoscopy\n\nExclusion Criteria:\n\n* contra-indication for thoracoscopy'}, 'identificationModule': {'nctId': 'NCT03558932', 'briefTitle': 'IP3R Modulation by Cancer Genes in Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'IP3R Modulation by Cancer Genes Bcl-2 & PKM2 in Mesothelioma', 'orgStudyIdInfo': {'id': 'IP3mesov1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pleural biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnostic sampling'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jonas Yserbyt', 'role': 'CONTACT', 'email': 'jonas.yserbyt@uzleuven.be', 'phone': '+32 16 34 68 01'}], 'overallOfficials': [{'name': 'Jonas Yserbyt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic university Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yserbyt Jonas', 'investigatorAffiliation': 'KU Leuven'}}}}