Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-17 @ 12:32 AM
Study NCT ID:
NCT03044834
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2017-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Review of the Paediatric Pleuropulmonary Blastoma French Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537516', 'term': 'Pleuropulmonary blastoma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Within 5 years from the diagnosis'}, {'measure': 'Progression free survival', 'timeFrame': 'Within 5 years from the diagnosis', 'description': 'Characterize the evolution and the global care of PPB in the French series'}], 'secondaryOutcomes': [{'measure': 'State of PPB surgical care', 'timeFrame': 'Within 5 years from the diagnosis'}, {'measure': 'Radiology sign', 'timeFrame': 'Within 5 years from the diagnosis', 'description': 'Identification of a type 1 PPB predictive radiological sign'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pleuropulmonary Blastoma']}, 'descriptionModule': {'briefSummary': 'Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were identified in 2009.\n\nThree histologies are described: type 1 purely cystic, type 2 combined and type 3 solid. Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is possible from type 1 to type 2 or 3 in 10% of the cases.\n\nSince 2009, DICER 1 mutations research is proposed systematically to all families.\n\nPPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can be difficult because of the proximity with congenital cystic adenomatoid malformation.\n\nThe French society of paediatric oncology recommends surgery at first instance. PPB type 1 remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy depends on the PPB type and the quality of the resection. There is a real interest to analyse the French series.\n\nThe prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1 survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary invasion and quality of surgery.\n\nEarly local relapses are possible and late ones concern more often type 2 and 3 with more cerebral metastasis.\n\nIn 2009, the french cases were collected, but no update has been performed since. The aim of this retrospective review of the cases since 2000, is to audit the care of PPB patients in France and update the French rare tumour database.\n\nEvoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion and PPB type 1. Radiological presentation is however overlapping. Another aim of this study will be to look for a predictive sign of type 1 PPB.', 'detailedDescription': 'Multicentre retrospective study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients born between 01/01/2000 and 01/01/2016, followed up for PPB, treated in a French department of paediatric oncology or paediatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients born between 01/01/2000 and 01/01/2016 ;\n* Followed up for PPB\n* Treated in a French department of paediatric oncology or paediatric surgery\n* Study agreement\n\nExclusion Criteria:\n\n* Part of the care out of France\n* Study disagreement'}, 'identificationModule': {'nctId': 'NCT03044834', 'acronym': 'PPB', 'briefTitle': 'Review of the Paediatric Pleuropulmonary Blastoma French Series', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Review of the Paediatric Pleuropulmonary Blastoma French Series', 'orgStudyIdInfo': {'id': '35RC15_3009_PPB'}, 'secondaryIdInfos': [{'id': '15.18', 'type': 'OTHER', 'domain': "Comité d'Ethique Régional de Rennes"}, {'id': '15.468', 'type': 'OTHER', 'domain': 'CCTIRS'}, {'id': '915465', 'type': 'OTHER', 'domain': 'CNIL'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pleuropulmonary Blastoma', 'description': '* Patients born between 01/01/2000 and 01/01/2016 ;\n* Followed up for PPB\n* Treated in a French department of paediatric oncology or paediatric surgery\n* Study agreement', 'interventionNames': ['Other: PPB']}], 'interventions': [{'name': 'PPB', 'type': 'OTHER', 'description': 'Global current care', 'armGroupLabels': ['Pleuropulmonary Blastoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '94000', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Kremlin-Bicêtre Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Lyon Universty Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Marseille University Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Necher Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '92000', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Curie Institute', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '97000', 'city': 'Saint-Paul', 'country': 'France', 'facility': 'Réunion University Hospital', 'geoPoint': {'lat': 49.42962, 'lon': 2.00755}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '94000', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy Institute', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Alexis ARNAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}