Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-30 @ 1:17 PM
Study NCT ID:
NCT04419935
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2020-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphadenectomy in NSCLC With and Without Adjuvant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the prognostic role of the number of resected and metastatic lymph nodes in pathologically node-positive NSCLC patients underwent surgical resection', 'timeFrame': '5 years', 'description': 'overall survival will be used to assess the prognostic role of number of resected and metastatic nodes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic Surgery', 'Adjuvant therapy'], 'conditions': ['NSCLC', 'Lymph Node Metastases']}, 'descriptionModule': {'briefSummary': 'Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2 disease, while the actual guidelines reported the possibility of a case-by-case decision in case of N1 involvement.\n\nOn the other hand, the actual categorization of patients based on the hilar or mediastinal involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM proposal for the N sub-classification, with a final proposal of different subgroups based on the number of involved stations. However, the IASLC committee noted that this proposal presented some limits due overlapping or not statistical significance among some survival curves, so the proposal was not adopted in the staging system. Moreover, the committee stated that the lack of information regarding some data such as the number of the resected or the metastatic nodes might affect the results and limited other proposals.\n\nThe objectives of this study are:\n\n* To evaluate the prognostic role of the kind of lymphadenectomy, the number of the resected and/or metastatic lymph nodes in surgically treated N positive patients in terms of survival.\n* To evaluate the indication and the role of adjuvant treatments in these patients.\n* To identify patients with increased risk of early recurrence or poor survival based on the lymph node involvement characteristics In particular, data will be collect in a prospective database including clinical and pathological data, kind of lymphadenectomy, number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant therapy and follow-up status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients affected by Non-Small Cell Lung Cancer underwent surgical treatment with anatomical resection + lymphadenectomy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Age \\>18 years\n* Non-Small Cell Lung Cancer Histology\n* Anatomical lung resection (segmentectomy, lobectomy or bilobectomy, pneumonectomy)\n* Pre-operative CT and PET evaluation\n* Preoperative and postoperative tumour board discussion\n* Intraoperative lymph node assessment (minimum 3 mediastinal stations harvested)\n* Lymph node metastases\n\nExclusion Criteria:\n\n* AGE \\< 18 years\n* Pregnancy\n* Psychiatric disease\n* Wedge resection\n* Distant metastases'}, 'identificationModule': {'nctId': 'NCT04419935', 'briefTitle': 'Lymphadenectomy in NSCLC With and Without Adjuvant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Prognostic Impact of the Kind of Lymphadenectomy and Lymph Node Characteristics on Node-positive Patients Underwent Anatomical Lung Resection With or Without Adjuvant Therapy for Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '3100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lymphadenectomy', 'type': 'PROCEDURE', 'otherNames': ['adjuvant therapy'], 'description': 'Lymphadenctomy according with ESTS guidelines'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Marco Chiappetta', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor - Principal Investigator', 'investigatorFullName': 'Chiappetta marco', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}