Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 6:54 PM
Study NCT ID:
NCT04592003
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2020-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Colorectal ESD Cohort in Experts Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0 Resection rate of submucosal dissection for superficial colorectal lesions', 'timeFrame': 'Month 1', 'description': 'R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy.'}], 'secondaryOutcomes': [{'measure': 'Endoscopic recurrence rate during the first endoscopic follow-up', 'timeFrame': 'Month 6', 'description': 'Recurrence during the first endoscopic follow-up will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.'}, {'measure': 'Monobloc resection rate', 'timeFrame': 'Day 1', 'description': 'Monobloc resection is defined as resection of the lesion in a single piece.'}, {'measure': 'Monobloc resection rate exclusively in ESD.', 'timeFrame': 'Day 1', 'description': 'Monobloc resection exclusively by ESD is defined as resection of the lesion in a single piece using submucosal dissection only, without the use of a diathermic loop (hybrid technique).'}, {'measure': 'Curative resection rate', 'timeFrame': 'Month 1', 'description': 'Curative resection is defined according to the recommendations of the European Society of Digestive Endoscopy as a monobloc R0 dissection without any negative anatomopathological criteria (well-differentiated lesion, no emboli, no budding \\> 1, submucosal infiltration \\< 1 mm).'}, {'measure': 'Optimal dissection rate', 'timeFrame': 'Month 1', 'description': 'Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed \\> 20 mm2/min.'}, {'measure': '30-day complication rate', 'timeFrame': 'Month 1', 'description': '* Per-procedural perforation: breach of the colonic musculature with visualization of the peritoneal cavity.\n* Post-procedural perforation (≤ 30 days): abdominal pain associated with fever or inflammatory syndrome and presence of extraluminal air on abdominal-pelvic CT scan, in the absence of per-procedural perforation.\n* Per-procedural hemorrhage: considered a complication only if it leads to interruption of the procedure.\n* Post-procedural hemorrhage: rectal bleeding or melena requiring hospitalization (or prolonged hospitalization) or endoscopic hemostasis.'}, {'measure': 'Curative endoscopic resection rate without surgical management at 36 months', 'timeFrame': 'Month 36', 'description': 'Curative endoscopic resection without surgery is defined by the absence of adenoma or adenocarcinoma at the resection scar after 36 months of follow-up, regardless of the number of endoscopic treatments required.'}, {'measure': 'Number of metachronous colorectal lesions at 36 months', 'timeFrame': 'Month 36', 'description': 'A metachronous lesion is defined as the presence of a new superficial colorectal lesion during one of the endoscopic checks, a lesion not visualized during one of the previous examinations.'}, {'measure': 'Surgery rate at 36 months', 'timeFrame': 'Month 36', 'description': 'Any colorectal surgery will be taken into account, whether due to failure of the endoscopic procedure, recurrence, a complication of the procedure, or an anatomopathological reason.'}, {'measure': 'Recurrence rate at 36 months', 'timeFrame': 'Month 36', 'description': 'Recurrence at 36 months will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.'}, {'measure': 'Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used.', 'timeFrame': 'Month 1', 'description': 'The histological prediction of resected lesions will be established using validated classifications (Paris, SANO, NICE, KUDO, JNET, CONECTT). It will be compared with the definitive histological results to assess their sensitivity, specificity, and diagnostic accuracy within the cohort.'}, {'measure': 'Impact of center volume on oncological outcomes, technical outcomes, and procedural complications.', 'timeFrame': 'Month 1', 'description': 'Oncological, technical, and complication outcomes will be analyzed according to the annual volume of the centers (low volume = \\< 50 ESDs per year; intermediate volume = between 50 and 100 procedures per year; high volume = \\> 100 procedures per year).'}, {'measure': 'Compare oncological and technical outcomes and procedural complications based on colonic or rectal location.', 'timeFrame': 'Month 1', 'description': 'Oncological, technical, and complication outcomes will be analyzed according to the colonic or rectal location of the lesion.'}, {'measure': 'Compare procedural outcomes based on the different traction strategies used', 'timeFrame': 'Month 1', 'description': 'Oncological, technical, and complication outcomes will be analyzed according to the traction system used for the procedure, matching lesions according to difficulty criteria validated by the literature.'}, {'measure': 'Analyze the learning curve of new trainees at the time of implementation of the submucosal dissection curriculum of the French Society of Digestive Endoscopy.', 'timeFrame': 'statitistic analysis', 'description': 'The learning curve of trainees will be used to evaluate oncological, technical, and complication outcomes using the LC CUSUM method.'}, {'measure': 'Creation of a difficulty score predicting the success of ESD (R0 resection without perforation)', 'timeFrame': 'Month 1', 'description': 'A difficulty score predicting success (R0 without perforation) will be created by performing a multivariate analysis according to the TRIPOD GUIDELINES using a derivation cohort and validated on a derivation cohort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer colorectal', 'Polyps colorectal', 'Endoscopic submucosal resection'], 'conditions': ['Cancer Colorectal', 'Polyps Colorectal', 'Endoscopic Submucosal Resection']}, 'referencesModule': {'references': [{'pmid': '41083216', 'type': 'DERIVED', 'citation': 'Van der Voort V, Schaefer M, Wallenhorst T, Lepilliez V, Degand T, Le Baleur Y, Leclercq P, Berger A, Chabrun E, Brieau B, Barret M, Rahmi G, Legros R, Rivory J, Leblanc S, Vanbiervliet G, Alfarone L, Magne J, Zeevaert JB, Albouys J, Perrod G, Yzet C, Lepetit H, Belle A, Chaussade S, Rostain F, Dahan M, Lupu A, Chevaux JB, Pioche M, Jacques J; FECCo Group collaborators. Rectal versus colonic submucosal cancer rates and procedural outcomes in large non-pedunculated polyps: French ESD registry data. Gut. 2025 Oct 12:gutjnl-2024-332970. doi: 10.1136/gutjnl-2024-332970. Online ahead of print.'}, {'pmid': '38684193', 'type': 'DERIVED', 'citation': 'Yzet C, Wallenhorst T, Jacques J, Figueiredo Ferreira M, Rivory J, Rostain F, Masgnaux LJ, Grimaldi J, Legros R, Lafeuille P, Albouys J, Subtil F, Schaefer M, Pioche M. Traction-assisted endoscopic submucosal dissection for resection of ileocecal valve neoplasia: a French retrospective multicenter case series. Endoscopy. 2024 Oct;56(10):790-796. doi: 10.1055/a-2316-4910. Epub 2024 Apr 29.'}, {'pmid': '37500072', 'type': 'DERIVED', 'citation': 'Yzet C, Le Baleur Y, Albouys J, Jacques J, Doumbe-Mandengue P, Barret M, Abou Ali E, Schaefer M, Chevaux JB, Leblanc S, Lepillez V, Privat J, Degand T, Wallenhorst T, Rivory J, Chaput U, Berger A, Aziz K, Rahmi G, Coron E, Kull E, Caillo L, Vanbiervliet G, Koch S, Subtil F, Pioche M. Use of endoscopic submucosal dissection or full-thickness resection device to treat residual colorectal neoplasia after endoscopic resection: a multicenter historical cohort study. Endoscopy. 2023 Nov;55(11):1002-1009. doi: 10.1055/a-2116-9930. Epub 2023 Jul 27.'}, {'pmid': '35649429', 'type': 'DERIVED', 'citation': 'Patenotte A, Yzet C, Wallenhorst T, Subtil F, Leblanc S, Schaefer M, Walter T, Lambin T, Fenouil T, Lafeuille P, Chevaux JB, Legros R, Rostain F, Rivory J, Jacques J, Lepilliez V, Pioche M. Diagnostic endoscopic submucosal dissection for colorectal lesions with suspected deep invasion. Endoscopy. 2023 Feb;55(2):192-197. doi: 10.1055/a-1866-8080. Epub 2022 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.\n\nScientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.\n\nA lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.\n\nThe aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.', 'detailedDescription': 'Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.\n\nScientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.\n\nA lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.\n\nThe aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients addressed for a colorectal ESD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients addressed for a colorectal ESD\n\nExclusion Criteria:\n\nOpposition notified in the context of a non-opposition form after reading the information notice'}, 'identificationModule': {'nctId': 'NCT04592003', 'acronym': 'FECCo', 'briefTitle': 'French Colorectal ESD Cohort in Experts Centers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'French Colorectal ESD Cohort in Experts Centers', 'orgStudyIdInfo': {'id': '87RI20-0021_FECCo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FECCo : French Esd Colorectal Cohort in Experts Centers', 'description': 'All patients over 18 years of age referred for submucosal dissection of a polyp or a colorectal LST in the French centers participating in the cohort.', 'interventionNames': ['Procedure: Endoscopic submucosal dissection']}], 'interventions': [{'name': 'Endoscopic submucosal dissection', 'type': 'PROCEDURE', 'description': 'Endoscopic submucosal dissection', 'armGroupLabels': ['FECCo : French Esd Colorectal Cohort in Experts Centers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clara CY YZET, Dr', 'role': 'CONTACT', 'email': 'yzet.clara@chu-amiens.fr'}], 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49044', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edouard EC CHABRUN, Dr', 'role': 'CONTACT', 'email': 'echabrun@gmail.com'}], 'facility': "Clinique de l'Anjou", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane SK KOCH, Dr', 'role': 'CONTACT', 'email': 'stephkoch65@gmail.com'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33400', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arthur AB BERGER, Dr', 'role': 'CONTACT', 'email': 'arthur.berger@chu-bordeaux.fr'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lucille LQ QUENERHVE, Dr', 'role': 'CONTACT', 'email': 'lucille.queneherve@gmail.com'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibault TD DEGAND, Dr', 'role': 'CONTACT', 'email': 'thibault.degand@chu-dijon.fr'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '87045', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémie JJ Jacques, Pr', 'role': 'CONTACT', 'email': 'jérémie.jacques@chu-limoges.fr', 'phone': '05 55 05 87 72'}], 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu MP PIOCHE, Pr', 'role': 'CONTACT', 'email': 'mathieu.pioche@chu-lyon.fr'}], 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent VL LEPILLIEZ, Dr', 'role': 'CONTACT'}, {'name': 'Sarah SL LEBALNC, Dr', 'role': 'CONTACT', 'email': 'arahleblanc34@hotmail.com'}], 'facility': 'Hôpital Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13003', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime MP PALAZZO, Dr', 'role': 'CONTACT', 'email': 'palazzomaxime@gmail.com'}], 'facility': 'Hôpital Européen', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34090', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine AB DEBOURDEAU, Dr', 'role': 'CONTACT', 'email': 'a-debourdeau@chu-montpellier.fr'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste JBC CHEVAUX, Dr', 'role': 'CONTACT', 'email': 'JB.CHEVAUX@chru-nancy.fr'}], 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand BB BRIEAU, Dr', 'role': 'CONTACT', 'email': 'bertrand.brieau@gmail.com'}], 'facility': 'Clinique Jules Vernes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel EC CORON, Pr', 'role': 'CONTACT', 'email': 'Emmanuel.CORON@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06200', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geoffroy VANBIERVLIET GW Geoffroy VANBIERVLIET, Pr', 'role': 'CONTACT', 'email': 'vanbiervliet.g@chu-nice.fr'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ludovic LC CAILLO, Dr', 'role': 'CONTACT', 'email': 'ludovic.caillo@chu-nimes.fr'}], 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier XD DRAY, Dr', 'role': 'CONTACT', 'email': 'xavier.dray@aphp.fr'}], 'facility': 'Hôpital St Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stanislas SC CHAUSSADE, Pr', 'role': 'CONTACT', 'email': 'stanislas.chaussade@aphp.fr'}], 'facility': 'Hôpital Cochin - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann YLB LE-BALEUR, Dr', 'role': 'CONTACT', 'email': 'ylebaleur@hpsj.fr'}], 'facility': 'Hôpital St Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel GR RAHMI, Pr', 'role': 'CONTACT', 'email': 'gabriel.rahmi@aphp.fr'}], 'facility': 'Hôpital Européen Georges Pompidou-APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Timothee TW WALLENHORST, Dr', 'role': 'CONTACT', 'email': 'timothee.wallenhorst@chu-rennes.fr'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chloé CM MELCHIOR, Pr', 'role': 'CONTACT', 'email': 'chloe.melchior@chu-rouen.fr'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44800', 'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas MUSQUER, Dr', 'role': 'CONTACT', 'email': 'drnicolasmusquer@outlook.fr'}], 'facility': 'Clinique Santé Atlantique', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lucile LH HEROIN, Dr', 'role': 'CONTACT', 'email': 'lucileheroin@gmail.com'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31400', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karl KB BARANGE, Dr', 'role': 'CONTACT', 'email': 'barange.k@chu-toulouse.fr'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Jérémie Jacques, Pr', 'role': 'CONTACT', 'email': 'jeremie.jacques@chu-limoges.fr', 'phone': '05 55 05 87 72'}, {'name': 'Juge Sandra, Dr', 'role': 'CONTACT', 'email': 'sandra.juge@chu-limoges.fr', 'phone': '05 55 05 64 14'}], 'overallOfficials': [{'name': 'Jérémie Jacques, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépato-Gastro-Entérologie et Nutrition du CHU de LIMOGES"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}