Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT05473403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2022-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multicenter, prognostic, non-randomized, comparative, longitudinal, prospective, external validation cohort, which aims to evaluate a decisional score previously developed in a retrospective cohort.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prospectively validate the previously elaborated SURFASA-score, evaluating its ability to predict non-response outcome to corticosteroid therapy in a new population of patients with acute severe autoimmune hepatitis.', 'timeFrame': 'Day 90', 'description': 'Patient response within 90 days to corticosteroid therapy defined as: responders (alive without LT) or non-responders (dead or transplanted) within 90 days since corticosteroid therapy introduction.'}], 'secondaryOutcomes': [{'measure': 'The association between infection occurrence and death during hospitalization', 'timeFrame': 'participation period (treatment+follow-up): 12 months', 'description': 'Documented infections during hospitalization'}, {'measure': 'the management of infected ASAIH patients in usual practice', 'timeFrame': 'participation period (treatment+follow-up): 12 months', 'description': 'Antibiotic therapy : doses'}, {'measure': 'The risk factors for early AIH flair after corticosteroid therapy response.', 'timeFrame': 'D90', 'description': 'The frequency of AIH flair'}, {'measure': 'The risk factors for AIH recurrence after liver transplantation', 'timeFrame': 'participation period (treatment+follow-up): 12 months', 'description': 'AIH recurrence'}, {'measure': 'The evolution of patients after LT', 'timeFrame': 'participation period (treatment+follow-up): 12 months', 'description': 'Retransplantation, alive, death'}, {'measure': 'The evolution of patients not treated with corticosteroids but meeting the inclusion and non-inclusion criteria', 'timeFrame': 'participation period (treatment+follow-up): 12 months', 'description': 'Retransplantation, alive, death'}, {'measure': 'The prognostic factors for survival in patients treated with corticosteroids who underwent or not LT', 'timeFrame': 'participation period (treatment+follow-up): 12 months', 'description': 'quality of the graft, immunosuppression, rejection episode,'}, {'measure': 'The association of histological features (liver biopsy) with response to corticosteroids and survival at 90 days since admission', 'timeFrame': '90 days', 'description': 'Presence of centrilobular necrosis and inflammatory infiltration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Severe AutoImmune Hepatitis (ASAIH)', 'Decisional score', 'Prognostic score'], 'conditions': ['Liver Failure, Acute', 'Hepatitis, Autoimmune', 'Organ Dysfunction Scores', 'Risk Factors']}, 'descriptionModule': {'briefSummary': 'Autoimmune hepatitis (AIH) is a chronic liver disease, which is characterized by the increase of immunoglobulin G (IgG) level, the presence of auto-antibodies and a typical histology, in the absence of other liver disease.\n\nDue to the heterogeneity of AIH manifestations, different scoring systems have been validated in order to make a reliable diagnosis. The two most recent scoring systems are: the revised International Autoimmune Hepatitis Group (IAIHG) criteria and the IAIHG simplified criteria. The second one is recommended by the European Association for the Study of the Liver (EASL) clinical practice guidelines (CPGs).\n\nThe EASL clinical practice guidelines suggests that the treatment of ASAIH (Acute Severe AIH) is high doses of corticosteroids (superior to 1mg/kg/day) as early as possible and a lack of improvement within seven days should lead to listing for emergency liver transplantation (LT). However, the "lack of improvement" is not objectively defined and the grading of recommendation is III (Opinions of respected authorities).\n\nThe hypothesis of the study is that the previously developed decisional score on a retrospective series will prospectively allow the differentiation between patients with ASAIH (Acute Severe AIH) who respond to corticosteroid therapy and should be maintained on treatment and patients who do not respond and should be rapidly evaluated for LT. The score will be computed at day 3 since corticosteroid introduction.', 'detailedDescription': "All the interventions (blood samples, imagery examinations, visits, liver biopsy, corticosteroid therapy, liver transplantation) will be performed following the standard of care for ASAIH. The investigators of the participating centers will not change their standard management for the study protocol. The management will follow the recommendation of EASL CPGs.\n\nThe prognostic score will allow to distinguish between patient's responders and non-responders to corticosteroid therapy in ASAIH. This knowledge will avoid the prolonged duration of the corticosteroid therapy in patients for whom this therapy is futile or harmful and rapidly select the patients for LT. Of course considering that the created score is decisional whether a patient is a candidate for LT, a prospective validation is mandatory to use it as a clinical tool for the day-to-day practice. This is the first prospective study on ASAIH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Strong clinical suspicion of severe acute autoimmune hepatitis defined by the presence of increased IgG and/or autoantibodies and/or histology characteristic of the disease in the absence of other causes of severe acute hepatitis.\n* International Normalized Ratio (INR) ≥ 1.5\n* Informed, written consent\n* Patient having the rights to French social insurance\n\nExclusion Criteria:\n\n* Previous medical history of chronic liver disease including autoimmune liver disease (AIH, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC) , alcoholic hepatitis etc.)\n* Other causes of acute severe hepatitis:\n\n * Hepatitis A Virus (HAV) hepatitis, defined by HAV Immunoglobulin M (IgM) antibodies\n * Hepatitis B Virus (HBV) hepatitis, defined by HBs antigen and HBV IgM antibodies\n * Hepatitis E Virus (HEV) hepatitis, defined by HEV IgM antibodies or positive HEV-RNA in immunosuppressed patients\n * Drug induced hepatitis, histologically proved or induced by well-known hepatotoxic substances\n * Acute hypoxemic hepatitis, context of shock, hypoxemia or heat shock\n * Budd-Chiari syndrome, diagnosed by imagery (Doppler ultrasound, CT scan)\n * Acute hepatitis in the context of a HELLP (Hemolysis, Elevated Liver enzymes and a Low Platelet count) syndrome or acute fatty liver of pregnancy\n* Use of corticosteroids 1 month before inclusion\n* Pregnant or lactating woman\n* Curator or guardianship or patient placed under judicial protection\n* Participation in other interventional research during the study'}, 'identificationModule': {'nctId': 'NCT05473403', 'acronym': 'PRO-SURFASA', 'briefTitle': 'Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study', 'orgStudyIdInfo': {'id': 'D20180121'}, 'secondaryIdInfos': [{'id': '2021-A01869-32', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corticosteroid therapy', 'description': 'Prednisone or Prednisolone or Methylprednisolone : Patient with ASAIH will be treated in oral or intravenous (IV) with high doses ( ≥ 1mg/kg/day) of corticosteroids (Prednisone or Prednisolone or Methylprednisolone) until relapse (confirmed by blood tests and clinical status) requiring an emergency Liver Transplantation (LT) or death.', 'interventionNames': ['Other: Corticosteroid therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Patient without corticosteroid therapy', 'description': 'Patient not treated will undergo to emergency Liver Transplantation (LT) or death.'}], 'interventions': [{'name': 'Corticosteroid therapy', 'type': 'OTHER', 'description': 'Administration of high doses of corticosteroids as early as possible. Patient non-responder to treatment should lead to listing for emergency liver transplantation (LT).', 'armGroupLabels': ['Corticosteroid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Adrien LANNES, MD', 'role': 'CONTACT', 'email': 'adrien.lannes@chu-angers.fr', 'phone': '33 (0)2.41.35.31.42'}, {'name': 'Adrien LANNES, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Angers, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Vincent DI MARTINO, MD', 'role': 'CONTACT', 'email': 'Vdimartino@chu-besancon.fr'}, {'name': 'Vincent DI MARTINO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs", 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'contacts': [{'name': 'Nathalie GANNE, MD', 'role': 'CONTACT', 'email': 'nathalie.ganne@aphp.fr', 'phone': '33 (0)1.48.02.66.66'}, {'name': 'Nathalie GANNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP, Hopital Avicenne, Service Hepatologie et Oncologie Hépatique', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Noemi REBOUX, MD', 'role': 'CONTACT', 'email': 'noemi.reboux@chu-brest.fr'}, {'name': 'Noemi REBOUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Isabelle OLLIVIER-HOURMAND, MD', 'role': 'CONTACT', 'email': 'ollivierhourmand-i@chu-caen.fr', 'phone': '33 (0)2.31.06.45.44'}, {'name': 'Isabelle OLLIVIER-HOURMAND, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'contacts': [{'name': 'Helene BARRAUD, MD', 'role': 'CONTACT', 'email': 'h.barraud@chu-tours.fr', 'phone': '33 (0)2.47.47.59.16'}, {'name': 'Helene BARRAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Anne MINELLO, MD', 'role': 'CONTACT', 'email': 'anne.minello@chu-dijon.fr', 'phone': '33 (0)3.80.29.37.50'}, {'name': 'Anne MINELLO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Alexandre LOUVET, MD', 'role': 'CONTACT', 'email': 'alexandre.louvet@chru-lille.fr'}, {'name': 'Alexandre LOUVET, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'contacts': [{'name': 'Marilyne DEBETTE-GRATIEN, MD', 'role': 'CONTACT', 'email': 'marilyne.gratien@chu-limoges.fr', 'phone': '33 (0)5.55.05.66.21'}, {'name': 'Marilyne DEBETTE-GRATIEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Jerome DUMORTIER, MD', 'role': 'CONTACT', 'email': 'jerome.dumortier@chu-lyon.fr', 'phone': '33 (0)4.72.11.01.09'}, {'name': 'Jerome DUMORTIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Teresa Maria ANTONINI-MICHELLE, MD', 'role': 'CONTACT', 'email': 'teresa.antonini@chu-lyon.fr'}, {'name': 'Teresa Maria ANTONINI-MICHELLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Olivia PIETRI, MD', 'role': 'CONTACT', 'email': 'opietri@hopital-saint-joseph.fr', 'phone': '33 (0)4 91 80 70 61'}, {'name': 'Olivia PIETRI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Joseph, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Lucy MEUNIER, MD', 'role': 'CONTACT', 'email': 'lucy.meunier@chu-montpellier.fr', 'phone': '33 (0)4.67.33.66.33'}, {'name': 'Lucy MEUNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Rodolphe ANTY, MD', 'role': 'CONTACT', 'email': 'anty.r@chu-nice.fr', 'phone': '33 (0)4.92.03.63.85'}, {'name': 'Rodolphe ANTY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU Nice, Hopital de l'Archet 2, Service Hepatologie", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'contacts': [{'name': 'Pascal POTIER, MD', 'role': 'CONTACT', 'email': 'pascal.potier@chr-orleans.fr', 'phone': '33 (0)2.38.22.96.43'}, {'name': 'Pascal POTIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Olivier CHAZOULLIERES, MD', 'role': 'CONTACT', 'email': 'olivier.chazouilleres@aphp.fr', 'phone': '33 (0)1.49.28.29.23'}, {'name': 'Olivier CHAZOULLIERES, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Marika RUDLER, MD', 'role': 'CONTACT', 'email': 'Marika.rudler@aphp.fr', 'phone': '33 (0)1.42.17.56.91'}, {'name': 'Marika RUDLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Charlotte MOULIADE, MD', 'role': 'CONTACT', 'email': 'charlotte.mouliade@aphp.fr'}, {'name': 'Charlotte MOULIADE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HP, Hopital Cochin Service Hepatologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'contacts': [{'name': 'Victor DE LEDINGHEN, MD', 'role': 'CONTACT', 'email': 'victor.deledinghen@chu-bordeaux.fr', 'phone': '33 (0)5.57.65.64.39'}, {'name': 'Victor DE LEDINGHEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Christine SILVAIN, MD', 'role': 'CONTACT', 'email': 'c.silvain@chu-poitiers.fr', 'phone': '33 (0)5.49.44.44.38'}, {'name': 'Christine SILVAIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU La Miletrie, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'contacts': [{'name': 'Alexandra HEURGUE-BERLOT, MD', 'role': 'CONTACT', 'email': 'aheurgue@chu-reims.fr', 'phone': '33 (0)3.26.78.78.78'}, {'name': 'Alexandra HEURGUE-BERLOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Pauline HOUSSEL-DEBRY, MD', 'role': 'CONTACT', 'email': 'pauline.houssel-debry@chu-rennes.fr', 'phone': '33 (0).99.28.42.98'}, {'name': 'Pauline HOUSSEL-DEBRY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Odile GORIA, MD', 'role': 'CONTACT', 'email': 'Odile.Goria@chu-rouen.fr'}, {'name': 'Odile GORIA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU Rouen, Service d'hepatogastro-enterologie", 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Camille BESCH, MD', 'role': 'CONTACT', 'email': 'camille.besch@chru-strasbourg.fr', 'phone': '33 (0)3.88.12.74.48'}, {'name': 'Camille BESCH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Christophe BUREAU, MD', 'role': 'CONTACT', 'email': 'bureau.c@chu-toulouse.fr', 'phone': '33 (0)5.61.77.25.27'}, {'name': 'Christophe BUREAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse, Hopital Rangueil, Service Hepatologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'Eleonora DE MARTIN, MD, PhD', 'role': 'CONTACT', 'email': 'eleonora.demartin@aphp.fr', 'phone': '33 (0)1.45.59.64.33'}, {'name': 'Eleonora DE MARTIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Eleonora DE MARTIN, MD, PhD', 'role': 'CONTACT', 'email': 'eleonora.demartin@aphp.fr', 'phone': '33 (0)1.45.59.64.33'}, {'name': 'Jean-Charles DUCLOS-VALLEE, MD, PhD', 'role': 'CONTACT', 'email': 'jean-charles.duclos-vallee@aphp.fr', 'phone': '33 (0)1.45.59.64.28'}], 'overallOfficials': [{'name': 'Eleonora DE MARTIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}