Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-03 @ 4:27 AM
Study NCT ID:
NCT03305133
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Slides (tumour materials) at diagnosis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)', 'timeFrame': 'Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016', 'description': 'Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis:\n\nThe frequency of PD-L1 expression determined by IHC will be as follow:\n\n* Negative PD-L1 tumours (\\<1% of positive tumour cells)\n* Positive PD-L1 tumours (\\> or = to 1% of positive tumour cells)\n* Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed)\n* High positive PD-L1 tumours (\\> or = 50% of positive tumour cells expressed)'}], 'secondaryOutcomes': [{'measure': 'Correlation of PD-L1 expression of tumour cells with clinical data', 'timeFrame': 'Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016', 'description': 'Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016', 'description': 'Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016', 'description': 'PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016', 'description': 'OS defined as the time from first treatment start to death for any cause expressed in months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Large Cell Lung Cancer', 'Neuroendocrine Carcinoma of Lung (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting a large-cell NEC taken in charge by investigational centres between January 1st, 2014 and December 31st, 2016.\n\nAlive patients will be identified during disease follow-up visit as per the local current practice and the study will be then proposed to them at that time.\n\nFor died patients, eligible patients will be identified by checking the files present at site by the Principal Investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> or = 18 years\n* Diagnosis of Large-cell NEC confirmed by centralised reading\n* Tumoral materials available and readable for PD-L1 labeling\n\nExclusion Criteria:\n\n* Other type of Lung cancers\n* Tumoral material not available or not readable for centralised reading\n* Tumoral material not available or not readable for PD-L1 labeling'}, 'identificationModule': {'nctId': 'NCT03305133', 'acronym': 'EPNEC', 'briefTitle': 'Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Francais De Pneumo-Cancerologie'}, 'officialTitle': 'Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)', 'orgStudyIdInfo': {'id': 'GFPC 03-2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immunohistochemistry', 'type': 'OTHER', 'description': 'The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Argenteuil', 'state': "VAL D'oise", 'country': 'France', 'facility': 'Centre Hospitalier D Argenteuil', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Site 12', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '20200', 'city': 'Bastia', 'country': 'France', 'facility': 'Site 05', 'geoPoint': {'lat': 42.70219, 'lon': 9.45123}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'Site 22', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Centre Hospitalier du Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Site 43', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Site 48', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Site 33', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '76503', 'city': 'Elbeuf', 'country': 'France', 'facility': 'Site 32', 'geoPoint': {'lat': 49.28669, 'lon': 1.00288}}, {'zip': '05000', 'city': 'Gap', 'country': 'France', 'facility': 'Site 04', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Les Oudairies', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire DUPUYTREN', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hospital du Cluzeau', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Limoges', 'country': 'France', 'facility': 'Site 00', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69495', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '78200', 'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'Site 25', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'Site 06', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '77108', 'city': 'Meaux', 'country': 'France', 'facility': 'Site 01', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'zip': '45032', 'city': 'Orléans', 'country': 'France', 'facility': 'Site 42', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Site 26', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '24019', 'city': 'Périgueux', 'country': 'France', 'facility': 'Site 19', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Site 02', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Site 18', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '76233', 'city': 'Rouen', 'country': 'France', 'facility': 'Site 17', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '83800', 'city': 'Toulon', 'country': 'France', 'facility': 'Site 14', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '69655', 'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'Site 11', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'overallOfficials': [{'name': 'Dominque Arpin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Francais De Pneumo-Cancerologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}