Viewing Study NCT05138094


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Study NCT ID: NCT05138094
Status: UNKNOWN
Last Update Posted: 2022-07-25
First Post: 2021-11-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to functional recovery', 'timeFrame': 'Expected average of 4 to 12 days postoperatively', 'description': 'A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.'}], 'secondaryOutcomes': [{'measure': 'R0 resection margin', 'timeFrame': '30 days postoperatively', 'description': 'Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days postoperatively', 'description': 'The length of hospital stay for the surgical procedure(s)'}, {'measure': 'Activity tracking using Fitbit™', 'timeFrame': '14 days pre-operatively and 60 days postoperatively', 'description': "A patient's functional recovery will also be assessed using the Fitbit smartwatch."}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'During the surgical procedure', 'description': 'Intraoperative blood loss in milliliters'}, {'measure': 'Operative time', 'timeFrame': 'Operative time from incision until last suture', 'description': 'Operative time in minutes'}, {'measure': 'Morbidity', 'timeFrame': '90-days postoperatively', 'description': 'Morbidity related to the surgical procedure(s)'}, {'measure': 'Postoperative bile leakage', 'timeFrame': '90-days postoperatively', 'description': 'Bile leakage occurring after the liver resection'}, {'measure': 'Postoperative anastomotic leakage', 'timeFrame': '90-days postoperatively', 'description': 'Anastomotic leakage occurring after the colorectal resection'}, {'measure': 'Conversion to open surgery', 'timeFrame': 'During the surgical procedure', 'description': 'Intra-operative conversion to an open or hand-assisted procedure'}, {'measure': 'Readmission rate', 'timeFrame': '90-days postoperatively', 'description': 'Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '1 year postoperatively', 'description': 'The physical, social and emotional well-being of the patient; assessed using the EuroQol 5d and European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 instruments.'}, {'measure': 'Reasons for delay of discharge after functional recovery', 'timeFrame': '30 days postoperatively', 'description': 'All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.'}, {'measure': 'Hospital and societal costs', 'timeFrame': '1 year postoperatively', 'description': 'All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.'}, {'measure': 'Three and five-year recurrence free survival', 'timeFrame': '5 years postoperatively', 'description': 'The proportion of patients which is free of recurrence of the malignant disease after resection of both the primary colorectal carcinoma and the liver metastases.'}, {'measure': 'Three and five-year overall survival', 'timeFrame': '5 years postoperatively', 'description': 'The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms Malignant', 'Neoplasm Metastasis']}, 'referencesModule': {'references': [{'pmid': '30069639', 'type': 'BACKGROUND', 'citation': "van der Poel MJ, Tanis PJ, Marsman HA, Rijken AM, Gertsen EC, Ovaere S, Gerhards MF, Besselink MG, D'Hondt M, Gobardhan PD. Laparoscopic combined resection of liver metastases and colorectal cancer: a multicenter, case-matched study using propensity scores. Surg Endosc. 2019 Apr;33(4):1124-1130. doi: 10.1007/s00464-018-6371-1. Epub 2018 Aug 1."}, {'pmid': '32958079', 'type': 'BACKGROUND', 'citation': 'Pan L, Tong C, Fu S, Fang J, Gu Q, Wang S, Jiang Z, Juengpanich S, Cai X. Laparoscopic procedure is associated with lower morbidity for simultaneous resection of colorectal cancer and liver metastases: an updated meta-analysis. World J Surg Oncol. 2020 Sep 21;18(1):251. doi: 10.1186/s12957-020-02018-z.'}, {'pmid': '32209911', 'type': 'BACKGROUND', 'citation': 'Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Metairie S, Paye F, Bourlier P, Adam R, Merdrignac A, Tual C, Le Pabic E, Sulpice L, Meunier B, Regimbeau JM, Bellissant E; METASYNC Study group. Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial. Ann Surg. 2021 Jan 1;273(1):49-56. doi: 10.1097/SLA.0000000000003848.'}, {'pmid': '28888775', 'type': 'BACKGROUND', 'citation': 'Gavriilidis P, Sutcliffe RP, Hodson J, Marudanayagam R, Isaac J, Azoulay D, Roberts KJ. Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. HPB (Oxford). 2018 Jan;20(1):11-19. doi: 10.1016/j.hpb.2017.08.008. Epub 2017 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* Diagnosed with primary CRC with resectable synchronous CRLMs (with or without neoadjuvant chemotherapy)\\*\n* Elective indication for MI combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to 3 segments with a maximum of 2 separate liver resections. The MI two-staged approach includes both the conventional strategy (first resection of primary colorectal tumor followed by liver resection for CRLMs) and liver-first strategy (first CRLMs resection followed by resection of colorectal primary tumor). Patients undergoing bilobar resections are eligible (if 3 or fewer segments are resected)\n* BMI between and including 18-35\n* Patients with American Society of Anesthesiologists (ASA) physical status I-III and the American College of Surgeons national surgical quality improvement project (ACS NSQIP) universal surgical risk score of ≤ 50% for serious complications\n\n * In case of neoadjuvant chemotherapy, time interval between last chemotherapy cycle and (first) surgery should be 4-6 weeks.\n\nExclusion Criteria:\n\n* Inability to give (written) informed consent.\n* Patients requiring a planned temporarily or permanent stoma after colorectal resection (all colectomies, including high anterior resection). Patients who will receive an unplanned stoma intraoperatively, will be analysed according to their initial treatment assignment.\n* Patients requiring multivisceral colorectal resection (all colectomies, including high anterior resection).\n* Indication for MI combined or staged low anterior resection, total mesorectal excision or abdominoperineal resection and liver resection of four or more segments (i.e., hemihepatectomy or more extensive resections).\n* Patients with peritoneal metastases.\n* Patients with ASA physical status IV-V and ACS NSQIP surgical risk score of \\> 50% for serious complications.\n* Repeat open hepatectomy\n* Surgical history of colorectal- or liver resection for neoplastic disease\n* Surgical history of major or complicated open abdominal surgery\n* Indication for concurrent thermal ablation\n* Medical history of thermal ablation of liver for malignancy\n* Unresectable extrahepatic metastases\n* Pre-operatively reconstruction of vessels/bile ducts is deemed necessary'}, 'identificationModule': {'nctId': 'NCT05138094', 'acronym': 'LIVACOR', 'briefTitle': 'LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Poliambulanza Istituto Ospedaliero'}, 'officialTitle': 'LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection', 'orgStudyIdInfo': {'id': 'NP3969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Minimally invasive two-stage resection', 'description': 'Minimally invasive resection of the primary colorectal carcinoma and liver metastases in two stages. The liver metastases or the colorectal carcinoma can be resected during the first surgical procedure.', 'interventionNames': ['Procedure: Minimally invasive two-stage resection']}, {'type': 'EXPERIMENTAL', 'label': 'Minimally invasive simultaneous resection', 'description': 'Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.', 'interventionNames': ['Procedure: Minimally invasive simultaneous resection']}], 'interventions': [{'name': 'Minimally invasive simultaneous resection', 'type': 'PROCEDURE', 'otherNames': ['Minimally invasive combined resection', 'Minimally invasive synchronous resection'], 'description': 'One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.', 'armGroupLabels': ['Minimally invasive simultaneous resection']}, {'name': 'Minimally invasive two-stage resection', 'type': 'PROCEDURE', 'otherNames': ['Minimally invasive sequential resection'], 'description': 'Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed', 'armGroupLabels': ['Minimally invasive two-stage resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dennis Wicherts, PhD', 'role': 'CONTACT'}, {'name': 'Dennis Wicherts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joep Knol, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '8500', 'city': 'Kortrijk', 'state': 'West Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': "Mathieu D'Hondt, PhD", 'role': 'CONTACT'}, {'name': "Mathieu D'Hondt, PhD", 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bart van Geluwe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '92140', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ibrahim Dagher, PhD', 'role': 'CONTACT'}, {'name': 'Ibrahim Dagher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Panagiotis Lainas, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Antoine-Béclère Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66119', 'city': 'Saarbrücken', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gregor Stavrou, MD', 'role': 'CONTACT'}, {'name': 'Gregor Stavrou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'zip': '80131', 'city': 'Naples', 'state': 'Calabria', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Troisi, PhD', 'role': 'CONTACT'}, {'name': 'Roberto Troisi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gaetano Luglio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federico II University Hospital'}, {'zip': '40124', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elio Jovine, PhD', 'role': 'CONTACT'}, {'name': 'Elio Jovine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michele Masetti, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simone Nicosia, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Azienda USL di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '41125', 'city': 'Modena', 'state': 'Emilia-Romagna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio di Benedetto, PhD', 'role': 'CONTACT'}, {'name': 'Fabrizio di Benedetto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paolo Magistri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '43126', 'city': 'Parma', 'state': 'Emilia-Romagna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Dalla Valle, PhD', 'role': 'CONTACT'}, {'name': 'Raffaele Dalla Valle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mario Giuffrida, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Parma University Hospital', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Felice Giuliante, PhD', 'role': 'CONTACT'}, {'name': 'Felice Giuliante, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roberto Persiani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '25124', 'city': 'Brescia', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mohammed Abu Hilal, PhD', 'role': 'CONTACT'}, {'name': 'Mohammed Abu Hilal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jasper Sijberden, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondazione Poliambulanza Istituto Ospedaliero', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Aldrighetti, PhD', 'role': 'CONTACT'}, {'name': 'Luca Aldrighetti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Raffaele University Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '10128', 'city': 'Turin', 'state': 'Piedmont', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Ferrero, PhD', 'role': 'CONTACT'}, {'name': 'Alessandro Ferrero, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paolo Massucco, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mauriziano Umberto I Hospital', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '60126', 'city': 'Ancona', 'state': 'The Marches', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Vivarelli, PhD', 'role': 'CONTACT'}, {'name': 'Marco Vivarelli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mario Guerrieri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrea Benedetti Cacciaguerra, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Umberto Cillo, PhD', 'role': 'CONTACT'}, {'name': 'Umberto Cillo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Enrico Gringeri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jacopo Lanari, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': 'L-1210', 'city': 'Luxembourg', 'status': 'RECRUITING', 'country': 'Luxembourg', 'contacts': [{'name': 'Edoardo Rosso, MD', 'role': 'CONTACT'}, {'name': 'Edoardo Rosso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier du Luxembourg', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}, {'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ronald van Dam, PhD', 'role': 'CONTACT'}, {'name': 'Ronald van Dam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jarno Melenhorst, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rutger-Jan Swijnenburg, PhD', 'role': 'CONTACT'}, {'name': 'Rutger-Jan Swijnenburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'N-0424', 'city': 'Oslo', 'state': 'Østlandet', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Bjørn Edwin, PhD', 'role': 'CONTACT'}, {'name': 'Bjørn Edwin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sheraz Yaqub, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Asmund Fretland, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '111123', 'city': 'Moscow', 'state': 'Moscow Oblast', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mikhail Efanov, PhD', 'role': 'CONTACT'}, {'name': 'Mikhail Efanov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mikhail Danilov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aslan Baychorov, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moscow Clinical Scientific Center'}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Benedetto Ielpo, PhD', 'role': 'CONTACT'}, {'name': 'Benedetto Ielpo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Rotellar, PhD', 'role': 'CONTACT'}, {'name': 'Fernando Rotellar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Navarrra Hospital (Clinica Universitaria)', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'state': 'North West England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Aali Sheen, PhD', 'role': 'CONTACT'}, {'name': 'Aali Sheen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE1 4LP', 'city': 'Newcastle', 'state': 'Northeast England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Steve White, PhD', 'role': 'CONTACT'}, {'name': 'Steve White, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'Northwest England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rafael Díaz-Nieto, PhD', 'role': 'CONTACT'}, {'name': 'Rafael Díaz-Nieto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Liverpool University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'South East England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'John Primrose, PhD', 'role': 'CONTACT'}, {'name': 'John Primrose, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alex Mirnezami, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SE5 9RS', 'city': 'London', 'state': 'Southeast England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Krishna Menon, PhD', 'role': 'CONTACT'}, {'name': 'Krishna Menon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amyn Haji, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "King's College Hospital NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Southwest England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Somaiah Aroori, PhD', 'role': 'CONTACT'}, {'name': 'Somaiah Aroori, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Plymouth NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'B15 1NT', 'city': 'Birmingham', 'state': 'West Midlands', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Robert Sutcliffe, MD', 'role': 'CONTACT'}, {'name': 'Robert Sutcliffe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shazad Ashraf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'Jasper Sijberden, MD', 'role': 'CONTACT', 'email': 'jasper.sijberden@poliambulanza.it', 'phone': '0031630150451'}, {'name': 'Professor Mohammed Abu Hilal, MD PhD', 'role': 'CONTACT', 'email': 'abuhilal9@gmail.com'}], 'overallOfficials': [{'name': 'Professor Mohammed Abu Hilal, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione Poliambulanza Istituto Ospedaliero'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione 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