Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT05198960
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'AVAJAK is an academic multicenter phase 3 prospective, randomized, and open label trial.\n\n\\> Randomization of the patients: Patients corresponding to inclusion criteria will be randomized based on a 1:1 distribution.\n\n* Experimental group (Patients allocated to receive low-dose DOAC, at the choice of the investigator)\n\n * Apixaban 2.5 mg BID or\n * Rivaroxaban 10 mg OD, at the choice of the investigator.\n* Control group (Patients allocated to receive LDA)\n\n \\- Aspirin 100 mg OD Dispensation of treatments every 6 months for 24 months\n* Stratification:\n\n * First stratification will be done by center\n * Second stratification will be done by pathology (PV/ET/ PreMF)\n * No stratification will be made based on DOAC drugs.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1308}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to occurrence of arterial or venous thromboembolic events.', 'timeFrame': 'Time to occurrence up to 24 months of patient follow-up', 'description': 'Nb and type of thrombotic events during the FU'}], 'secondaryOutcomes': [{'measure': 'Time to occurrence of major and clinically relevant non-major bleedings as defined by International Society on Thrombosis and Haemostasis', 'timeFrame': 'Time to occurrence up to 24 months of patient follow-up', 'description': 'Nb and type of new hemorrhagic events'}, {'measure': 'Time to occurrence of arterial thromboembolic events.', 'timeFrame': 'Time to occurrence up to 24 months of patient follow-up', 'description': 'Nb and type of new arterial events'}, {'measure': 'Time to occurrence of venous thromboembolic', 'timeFrame': 'Time to occurrence up to 24 months of patient follow-up', 'description': 'Nb and type of new venous events'}, {'measure': 'Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs', 'timeFrame': 'Time to occurrence up to 24 months of patient follow-up', 'description': 'Nb and type of new thromboembolic and hemorrhage events'}, {'measure': 'Time to occurrence of serious adverse events others than thromboses and hemorrhages hemorrhages', 'timeFrame': 'Time to occurrence up to 24 months of patient follow-up', 'description': 'Nb, type and grade of adverse events observed'}, {'measure': 'Overall survival and event-free survival', 'timeFrame': '24 months', 'description': 'Time to last news and time to first event'}, {'measure': 'Therapeutic adherence', 'timeFrame': '24 months', 'description': 'Therapeutic adherence by Girerd auto-questionnaire'}, {'measure': 'Occurrence of atrial fibrillation episode (time to occurrence).', 'timeFrame': '24 months', 'description': 'Nb and timing of atrial fibrillation event'}, {'measure': 'Evaluation of Quality of life under antithrombotic drugs', 'timeFrame': '24 months', 'description': 'Evaluation of QoL by the use of MPN-SAF Quality of life'}, {'measure': 'Evaluation of costs and incremental cost utility ratio of low-dose DOAC compared to low-dose aspirin', 'timeFrame': '24 months', 'description': 'Evaluation of benefits/costs under antithrombotic drugs'}, {'measure': 'Evaluation of Quality of life under antithrombotic drugs', 'timeFrame': '24 months', 'description': 'Evaluation of QoL by the use of EQ-5D-5L Quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous ThromboEmbolism', 'Arterial Thrombosis', 'Hemorrhage'], 'conditions': ['Polycythemia Vera', 'Essential Thrombocythemia', 'Prefibrotic/Early Primary Myelofibrosis', 'JAK2 V617F', 'High-risk Patients']}, 'descriptionModule': {'briefSummary': 'Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases.\n\nThese diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status.\n\nIn terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events.\n\nDespite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients/year.\n\nAll these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events.\n\nAt the present time, DOAC can be used in cancer populations according to International Society on Thrombosis and Haemostasis (ISTH) recommendations, except in patients with cancer at high bleeding risk (gastro-intestinal or genito-urinary cancers). Unfortunately, in trials evaluating DOAC in cancer patients, most patients have solid rather than hematologic cancers (generally less than 10% of the patients, mostly lymphoma or myeloma).\n\nIn cancer patients, DOAC are also highly efficient to reduce the incidence of thrombosis (-30 to 60%), but patients are exposed to a higher hemorrhagic risk, especially in digestive cancer patients.\n\nIn the cancer population, pathophysiology of both thrombotic and hemorrhagic events may be quite different between solid cancers and MPN. If MPN patients are also considered to be cancer patients in many countries, the pathophysiology of thrombosis is quite specific (hyperviscosity, platelet abnormalities, clonality, specific cytokines…) and they are exposed to a lower risk of digestive hemorrhages. It is thus difficult to extend findings from the "general cancer population" to MPN patients.\n\nUnfortunately, only scarce, retrospective data regarding the use of DOAC in MPNs are available data.\n\nWe were the first to publish a "real-life" study about the use, the impact, and the risks in this population. In this local retrospective study, 25 patients with MPN were treated with DOAC for a median time of 2.1 years. We observed only one thrombosis (4%) and three major hemorrhages (12%, after trauma or unprepared surgery). Furthermore, we have compared the benefit/risk balance compared to patients treated with LDA without difference.\n\nWith the increasing evidences of efficacy and tolerance of DOAC in large cohorts of patients including cancer patients, with their proven efficacy on prevention of both arterial and venous thrombotic events and because of the absence of prospective trial using these drugs in MPN patients, we propose to study their potential benefit as primary thrombotic prevention in MPN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of PV or ET or PreMF according to WHO or BSCH criteria (bone marrow biopsy not compulsory).\n* Patients with JAK2V617F mutation (threshold allele burden \\> 1%).\n* Patients considered as "high-risk" patients:\n\n 1. based on age (\\> 60-year-old)\n 2. based on thrombotic history (compatible with antithrombotic randomization) but aged ≥ 18-year-old.\n* Length of time from MPN diagnostic to inclusion will not exceed 12 months.\n\nExclusion Criteria:\n\n* Contra-indication to aspirin or DOAC due to allergic situation or recent history of major bleeding.\n* Formal indication of treatment with aspirin or DOAC (thus precluding randomization).\n* Inability to give informed consent.\n* Patients under curatorship/guardianship\n* Concomitant use of a strong inhibitor or inducer of CYP3A4 (like ruxolitinib).\n* Chronic liver disease or chronic hepatitis.\n* Renal insufficiency with creatinine \\<30 ml/mn on Cockcroft and Gault Formula\n* Patient considered at high-risk of bleeding: patients with current or recent major or clinical relevant non major bleeding gastrointestinal or cerebral bleedings\n* Planned pregnancy within 24 months\n* No appropriate contraception (estrogen contraception or no contraception) in women of childbearing age or breastfeeding woman\n* PS\\>2 or life expectancy \\<12 months.'}, 'identificationModule': {'nctId': 'NCT05198960', 'acronym': 'AVAJAK', 'briefTitle': 'AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': '29BRC20.0263 (AVAJAK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients randomized to receive Direct Oral Anticoagulants, at the choice of the investigator Apixaban 2.5 mg both in day or Rivaroxaban 10 mg one per day, at the choice of the investigator', 'interventionNames': ['Drug: Direct Oral Anticoagulants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients randomized to receive Low-Dose Aspirin Aspirin 100 mg one per day', 'interventionNames': ['Drug: Low-dose aspirin']}], 'interventions': [{'name': 'Direct Oral Anticoagulants', 'type': 'DRUG', 'description': 'Patients randomized to receive DOAC, at the choice of the investigator: Apixaban 2.5 mg both in day or Rivaroxaban 10 mg once daily.', 'armGroupLabels': ['Experimental group']}, {'name': 'Low-dose aspirin', 'type': 'DRUG', 'description': 'Patients allocated to receive LDA: Aspirin 100 mg OD once daily.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corentin ORVAIN, PH', 'role': 'CONTACT', 'email': 'corentin.orvain@chu-angers.fr', 'phone': '+33615270461'}, {'name': 'Corentin ORVAIN, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '74374', 'city': 'Annecy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne PARRY, PH', 'role': 'CONTACT', 'email': 'aparry@ch-annecygenevois.fr', 'phone': '+33450635101'}, {'name': 'Anne PARRY, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CH d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '95100', 'city': 'Argenteuil', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Annalisa ANDREOLI, PH', 'role': 'CONTACT', 'email': 'annalisa.andreoli@ch-argenteuil.fr'}, {'name': 'Annalisa ANDREOLI, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CH d'Argenteuil", 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84000', 'city': 'Avignon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Borhane SLAMA, PH', 'role': 'CONTACT', 'email': 'bslama@ch-avignon.fr'}, {'name': 'Borhane SLAMA, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CH d'Avignon", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64100', 'city': 'Bayonne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric BAUDUER, PH', 'role': 'CONTACT', 'email': 'frederic.bauduer@u-bordeaux.fr'}, {'name': 'Frédéric BAUDUER, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de la Côte Basque Bayonne', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '34500', 'city': 'Béziers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain Radwan SAAD, PH', 'role': 'CONTACT', 'email': 'alain.saad@ch-beziers.fr'}, {'name': 'Alain Radwan SAAD, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Béziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '33604', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence MEDIAVILLA, PH', 'role': 'CONTACT', 'email': 'clemence.mediavilla@chu-bordeaux.fr'}, {'name': 'Clémence MEDIAVILLA, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe Ianotto, PUPH', 'role': 'CONTACT', 'email': 'jean-christophe.ianotto@chu-brest.fr'}, {'name': 'Jean-Christophe Ianotto, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '35510', 'city': 'Cesson-Sévigné', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoît BAREAU, PH', 'role': 'CONTACT', 'email': 'benoit.bareau@gmail.com'}, {'name': 'Benoît BAREAU, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital privé Cesson-Sévigné', 'geoPoint': {'lat': 48.1212, 'lon': -1.603}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoît DE RENZIS, PH', 'role': 'CONTACT', 'email': 'bderenzis@chu-clermontferrand.fr'}, {'name': 'Benoît DE RENZIS, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lydia ROY, PH', 'role': 'CONTACT', 'email': 'lydia.roy@aphp.fr'}, {'name': 'Lydia ROY, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Henri Mondor (APHP)', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu MEUNIER, PH', 'role': 'CONTACT', 'email': 'mmeunier2@chu-grenoble.fr'}, {'name': 'Mathieu MEUNIER, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno VILLEMAGNE, PH', 'role': 'CONTACT', 'email': 'bruno.villemagne@chd-vendee.fr'}, {'name': 'Bruno VILLEMAGNE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHD Vendée La Roche Sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '76083', 'city': 'Le Havre', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre LEBRETON, PH', 'role': 'CONTACT', 'email': 'pierre.lebreton@ch-havre.fr'}, {'name': 'Pierre LEBRETON, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Le Havre', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '72000', 'city': 'Le Mans', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Kamel LARIBI, PH', 'role': 'CONTACT', 'email': 'klaribi@ch-lemans.fr'}, {'name': 'Kamel LARIBI, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '33500', 'city': 'Libourne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diane LARA, PH', 'role': 'CONTACT', 'email': 'Diane.Lara@ch-libourne.fr'}, {'name': 'Diane LARA, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Libourne', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amélie PENOT, PH', 'role': 'CONTACT', 'email': 'amelie.penot@chu-limoges.fr'}, {'name': 'Amélie PENOT, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Limoges - Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69000', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck-Emmanuel NICOLINI, PH', 'role': 'CONTACT', 'email': 'franc-emmanuel.nicolini@lyon-unicancer.fr'}, {'name': 'Franck-Emmanuel NICOLINI, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Léon Bérard Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franciane PAUL, PH', 'role': 'CONTACT', 'email': 'f-paul@chu-montpellier.fr'}, {'name': 'Franciane PAUL, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '29600', 'city': 'Morlaix', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe NICOL, PH', 'role': 'CONTACT', 'email': 'cnicol@ch-morlaix.fr'}, {'name': 'Christophe NICOL, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '54511', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dana RANTA, PH', 'role': 'CONTACT', 'email': 'd.ranta@chu-nancy.fr'}, {'name': 'Dana RANTA, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Viviane DUBRUILLE, PH', 'role': 'CONTACT', 'email': 'viviane.dubruille@chu-nantes.fr'}, {'name': 'Viviane DUBRUILLE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nantes - Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44202', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Katell LE DU, PH', 'role': 'CONTACT', 'email': 'dr.ledu@groupeconfluent.fr'}, {'name': 'Katell LE DU, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé du Confluent Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45100', 'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marlène OCHMANN, PH', 'role': 'CONTACT', 'email': 'marlene.ochmann@chr-orleans.fr'}, {'name': 'Marlène OCHMANN, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHR d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Jacques KILADJIAN, PUPH', 'role': 'CONTACT', 'email': 'jean-jacques.kiladjian@aphp.fr'}, {'name': 'Jean-Jacques KILADJIAN, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital St-Louis (APHP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michaela FONTENAY, PH', 'role': 'CONTACT', 'email': 'michaela.fontenay@aphp.fr'}, {'name': 'Michaela FONTENAY, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cochin (APHP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66000', 'city': 'Perpignan', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Virginie ROLAND, PH', 'role': 'CONTACT', 'email': 'virginie.roland@ch-perpignan.fr'}, {'name': 'Virginie ROLAND, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '24019', 'city': 'Périgueux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire CALMETTE, PH', 'role': 'CONTACT', 'email': 'claire.calmettes@ch-perigueux.fr'}, {'name': 'Claire CALMETTE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '29107', 'city': 'Quimper', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lénaïg LE CLECH, PH', 'role': 'CONTACT', 'email': 'l.leclech@ch-cornouaille.fr'}, {'name': 'Lénaïg LE CLECH, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHIC de Quimper', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '35033', 'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc BERNARD, PH', 'role': 'CONTACT', 'email': 'marc.nernard@chu-rennes.fr'}, {'name': 'Marc BERNARD, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '17300', 'city': 'Rochefort', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume DENIS, PH', 'role': 'CONTACT', 'email': 'guillaume.denis@ch-rochefort.fr'}, {'name': 'Guillaume DENIS, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Rochefort', 'geoPoint': {'lat': 45.94304, 'lon': -0.96774}}, {'zip': '59100', 'city': 'Roubaix', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu WEMEAU, PH', 'role': 'CONTACT', 'email': 'mathieu.wemeau@chu-roubaix.fr'}, {'name': 'Mathieu WEMEAU, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '76038', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice JARDIN, PH', 'role': 'CONTACT', 'email': 'fabrice.jardin@chb.unicancer.fr'}, {'name': 'Fabrice JARDIN, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Henri Becquerel de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '97405', 'city': 'Saint-Denis', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane VANDERBECKEN, PH', 'role': 'CONTACT', 'email': 'stephane.vanderbecken@chu-reunion.fr'}, {'name': 'Stéphane VANDERBECKEN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU La Réunion - Site Nord Félix GUYON', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97410', 'city': 'Saint-Pierre', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Raphaëlle DINE, PH', 'role': 'CONTACT', 'email': 'raphaelle.dine@chu-reunion.fr'}, {'name': 'Raphaëlle DINE, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU La Réunion - Site Sud', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '42271', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie CHALAYER, PH', 'role': 'CONTACT', 'email': 'emilie.chalayer@icloire.fr'}, {'name': 'Emilie CHALAYER, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Cancérologie Lucien Neuwirth St-Priest-en-Jarez', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '92210', 'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anaïse BLOUET, PH', 'role': 'CONTACT', 'email': 'ablouet@solcrr.org'}, {'name': 'Anaïse BLOUET, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Sainte Anne Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine MACHET, PH', 'role': 'CONTACT', 'email': 'a.machet@chu-tours.fr'}, {'name': 'Antoine MACHET, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '56017', 'city': 'Vannes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mélanie MERCIER, PH', 'role': 'CONTACT', 'email': 'melanie.mercier@ch-bretagne-atlantique.fr'}, {'name': 'Mélanie MERCIER, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Bretagne Atlantique Vannes', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'zip': '78150', 'city': 'Versailles', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Juliette LAMBERT, PH', 'role': 'CONTACT', 'email': 'jlambert@ch-versailles.fr'}, {'name': 'Juliette LAMBERT, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Versailles', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'zip': '94800', 'city': 'Villejuif', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence LE GROS, PH', 'role': 'CONTACT', 'email': 'laurence.legros@aphp.fr'}, {'name': 'Laurence LE GROS, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Paul-Brousse (APHP)', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69616', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathias BREHON, PH', 'role': 'CONTACT', 'email': 'm.brehon@resamut.fr'}, {'name': 'Mathias BREHON, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Médipôle Hôpital Mutualiste Villeurbanne', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'centralContacts': [{'name': 'Jean-Christophe IANOTTO, Pr', 'role': 'CONTACT', 'email': 'jean-christophe.ianotto@chu-brest.fr', 'phone': '+33298223421'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning five years and ending fifteen years following the final study report completion.', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}