Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04048512
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2019-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of ExtraCorporeal Membrane Oxygenator(ECMO) or Cardio Pulmonary By Pass (CPB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the number of circulating tumor cells the day before surgery and first post operative day (24 hours after surgery)', 'timeFrame': 'The day before surgery and the first post operative day (24 hours after surgery)', 'description': 'Quantification of CTC (number) in peripheral blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Surgery', 'Cardiopulmonary Bypass']}, 'referencesModule': {'references': [{'pmid': '14736930', 'type': 'BACKGROUND', 'citation': 'Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med. 2004 Jan 22;350(4):379-92. doi: 10.1056/NEJMra035536. No abstract available.'}, {'pmid': '12371586', 'type': 'BACKGROUND', 'citation': 'Rice TW, Blackstone EH. Radical resections for T4 lung cancer. Surg Clin North Am. 2002 Jun;82(3):573-87. doi: 10.1016/s0039-6109(02)00017-8.'}, {'pmid': '16242466', 'type': 'BACKGROUND', 'citation': 'Regnard JF, Perrotin C, Giovannetti R, Schussler O, Petino A, Spaggiari L, Alifano M, Magdeleinat P. Resection for tumors with carinal involvement: technical aspects, results, and prognostic factors. Ann Thorac Surg. 2005 Nov;80(5):1841-6. doi: 10.1016/j.athoracsur.2005.04.032.'}, {'pmid': '16399298', 'type': 'BACKGROUND', 'citation': 'de Perrot M, Fadel E, Mercier O, Mussot S, Chapelier A, Dartevelle P. Long-term results after carinal resection for carcinoma: does the benefit warrant the risk? J Thorac Cardiovasc Surg. 2006 Jan;131(1):81-9. doi: 10.1016/j.jtcvs.2005.07.062. Epub 2005 Dec 5.'}, {'pmid': '23103000', 'type': 'BACKGROUND', 'citation': 'Perentes J, Bopp S, Krueger T, Gonzalez M, Jayet PY, Lovis A, Matzinger O, Ruffieux C, Ris HB, Letovanec I, Peters S. Impact of lung function changes after induction radiochemotherapy on resected T4 non-small cell lung cancer outcome. Ann Thorac Surg. 2012 Dec;94(6):1815-22. doi: 10.1016/j.athoracsur.2012.08.054. Epub 2012 Oct 25.'}, {'pmid': '8166550', 'type': 'BACKGROUND', 'citation': 'Tsuchiya R, Asamura H, Kondo H, Goya T, Naruke T. Extended resection of the left atrium, great vessels, or both for lung cancer. Ann Thorac Surg. 1994 Apr;57(4):960-5. doi: 10.1016/0003-4975(94)90214-3.'}, {'pmid': '8694588', 'type': 'BACKGROUND', 'citation': 'Rao V, Todd TR, Weisel RD, Komeda M, Cohen G, Ikonomidis JS, Christakis GT. Results of combined pulmonary resection and cardiac operation. Ann Thorac Surg. 1996 Aug;62(2):342-6; discussion 346-7.'}, {'pmid': '24740936', 'type': 'BACKGROUND', 'citation': 'Lang G, Ghanim B, Hotzenecker K, Klikovits T, Matilla JR, Aigner C, Taghavi S, Klepetko W. Extracorporeal membrane oxygenation support for complex tracheo-bronchial proceduresdagger. Eur J Cardiothorac Surg. 2015 Feb;47(2):250-5; discussion 256. doi: 10.1093/ejcts/ezu162. Epub 2014 Apr 16.'}, {'pmid': '21718853', 'type': 'BACKGROUND', 'citation': 'Lang G, Taghavi S, Aigner C, Charchian R, Matilla JR, Sano A, Klepetko W. Extracorporeal membrane oxygenation support for resection of locally advanced thoracic tumors. Ann Thorac Surg. 2011 Jul;92(1):264-70. doi: 10.1016/j.athoracsur.2011.04.001.'}, {'pmid': '7546803', 'type': 'BACKGROUND', 'citation': 'Brutel de la Riviere A, Knaepen P, Van Swieten H, Vanderschueren R, Ernst J, Van den Bosch J. Concomitant open heart surgery and pulmonary resection for lung cancer. Eur J Cardiothorac Surg. 1995;9(6):310-3; discussion 313-4. doi: 10.1016/s1010-7940(05)80188-5.'}]}, 'descriptionModule': {'briefSummary': 'The role of circulating tumor cells (CTC) in patients suffering from lung cancer and thoracic malignancies is not well known and it is still widely debated. The use of intraoperative cardiorespiratory supports like ECMO (extracorporeal membrane oxygenator) and CPB (cardiopulmonary by-pass) during extended resections in oncologic patients has been questioned because of the theoretical risk of tumor cells spreading, although there is no clinical or experimental evidence supporting this hypothesis.\n\nThe aim of the present study is to quantify the possible presence and amount of CTC in the peripheral blood of patients undergoing lung/mediastinal resection, before and after surgical procedure, comparing patients receiving intraoperative cardiorespiratory support with patients - with similar oncologic disease and extension - operated without the need of ECMO or CPB.', 'detailedDescription': 'Background and Rationale:\n\nLocally advanced pulmonary and mediastinal cancers invading vital structure such as heart, great vessels, or carina cancer are generally considered as unresectable and incurable. Complete resection in healthy tissue may be compromised due to the proximity of the tumors to vital organs \\[1, 2\\]. Palliation with chemotherapy and/or radiotherapy is the principal means of treatment \\[1, 2\\]. In highly selected patients with specific anatomic conditions, complete R0 resection for locally advanced tumor has been reported with prolonged survival and, on occasion, resulted in cure \\[3-5\\]. Complex cardiac resections or reconstructions, replacement of the thoracic aorta, or the common pulmonary artery can only be approached with cardiac arrest and total circulatory support by standard cardio-pulmonary bypass (CPB) \\[6,7\\]; extracorporeal membrane oxygenation (ECMO) is a well- established technique for the management of respiratory or hemodynamic disturbance during lung transplantation. Technological advances in pumps, cannulae, and oxygenators and growing experience for thoracic surgeon during lung transplantation have led to the use of ECMO during conventional thoracic surgical procedure \\[8,9\\].\n\nA theoretical possibility of enhancement of metastasis due to ECMO or CPB has been reported \\[10\\] although no clear evidence exists ; nevertheless, due to the lack of data about this aspect, many cardio-thoracic surgeons are skeptical about the use of intraoperative CPB or ECMO .\n\nThe aim of this protocol is to assess the presence or not and possibly the amount of CTC before and after surgery in the peripheral blood of patients undergoing thoracic resection with (experimental arm) or without (control arm) intraoperative support of ECMO or CPB.\n\nStudy design and duration Prospective, double arm , observational study.\n\nTen consecutive patients - with thoracic malignancies undergoing resection with planned intraoperative cardiorespiratory support - will be enrolled. Before surgery peripheral blood samples will be collected (as subsequently described) to search the presence and the amount of CTC. The patients will then undergo surgical procedure with intraoperative ECMO or CPB support. After the procedure peripheral blood samples will be collected as previously reported to search for CTC.\n\nTen consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC.\n\nThe two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ten consecutive patients with planned intraoperative cardiorespiratory support will be enrolled and blood samples will be collected to search for CTC. The patients will then undergo operation with Extra Corporeal membarne Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB) support. After the procedure peripheral blood samples will be collected as previously reported to search for Circulating Tumor Cells (CTC).\n\nTen consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC.\n\nThe two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thoracic resection (lung and or mediastinal resection) requiring intraoperative Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) support; in the control group same disease and planned procedure to be performed without the need of EMCO or CPB.\n* Infiltration of the main carina\n* Infiltration of superior vena cava\n* Single lung surgery\n* Mediastinal involvment\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Contraindications to general anesthesia\n* Poor general clinical conditions ( ECOG PS \\>=2)\n* Patients unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04048512', 'briefTitle': 'Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of ExtraCorporeal Membrane Oxygenator(ECMO) or Cardio Pulmonary By Pass (CPB)', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB)', 'orgStudyIdInfo': {'id': 'R1005/19-IEO 1060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Resection with intraoperative ECMO/CPB', 'description': 'Patients suffering of neoplastic thoracic disease, undergoing thoracic resection with intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB)', 'interventionNames': ['Procedure: Resection with intraoperative use of ECMO/CPB']}, {'label': 'Resection without intraoperative ECMO/CPB', 'description': 'Patients suffering of neoplastic thoracic disease, undergoing thoracic resection without intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio pulmonary By Pass (CPB)', 'interventionNames': ['Procedure: Resection without intraoperative use of ECMO/CPB']}], 'interventions': [{'name': 'Resection with intraoperative use of ECMO/CPB', 'type': 'PROCEDURE', 'description': 'Patients are operated with the use of intraoperative ECMO/CPB', 'armGroupLabels': ['Resection with intraoperative ECMO/CPB']}, {'name': 'Resection without intraoperative use of ECMO/CPB', 'type': 'PROCEDURE', 'description': 'Patients are operated without the use of intraoperative ECMO/CPB', 'armGroupLabels': ['Resection without intraoperative ECMO/CPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20143', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Petrella, MD, Ph D', 'role': 'CONTACT', 'email': 'francesco.petrella@ieo.it', 'phone': '00390294372921'}], 'facility': 'European Institue of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Francesco Petrella, MD, PhD', 'role': 'CONTACT', 'email': 'francesco.petrella@ieo.it', 'phone': '00393388231311'}], 'overallOfficials': [{'name': 'Francesco Petrella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}