Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-28 @ 1:45 AM
Study NCT ID:
NCT02834169
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2016-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French National Registry of Rare Peritoneal Surface Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011553', 'term': 'Pseudomyxoma Peritonei'}, {'id': 'D058405', 'term': 'Desmoplastic Small Round Cell Tumor'}, {'id': 'D018284', 'term': 'Cystadenocarcinoma, Serous'}], 'ancestors': [{'id': 'D002288', 'term': 'Adenocarcinoma, Mucinous'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D003536', 'term': 'Cystadenocarcinoma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2171}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-18', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of rare peritoneal surface malignancies', 'timeFrame': 'year 5', 'description': 'Collect detailed clinical and histological diagnosis for estimating annual incidence rate'}], 'secondaryOutcomes': [{'measure': 'Impact of specific treatment strategies', 'timeFrame': 'year 5', 'description': 'Collect detailed therapeutic strategies (surgical procedure, chemotherapy, etc.) on patients with rare peritoneal surface malignancies'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rare peritoneal surface malignancies', 'pseudomyxoma peritonei', 'peritoneal mesothelioma', 'desmoplastic small round cell tumor', 'psammocarcinoma', 'primary peritoneal serous carcinoma', 'diffuse peritoneal leiomyomatosis', 'appendiceal mucinous neoplasms', 'registry', 'population-based database'], 'conditions': ['Rare Peritoneal Surface Malignancies', 'Pseudomyxoma Peritonei', 'Peritoneal Mesothelioma', 'Desmoplastic Small Round Cell Tumor', 'Psammocarcinoma', 'Primary Peritoneal Serous Carcinoma', 'Diffuse Peritoneal Leiomyomatosis', 'Appendiceal Mucinous Neoplasms']}, 'referencesModule': {'references': [{'pmid': '28212684', 'type': 'DERIVED', 'citation': 'Villeneuve L, Passot G, Glehen O, Isaac S, Bibeau F, Rousset P, Gilly FN; RENAPE Network. The RENAPE observational registry: rationale and framework of the rare peritoneal tumors French patient registry. Orphanet J Rare Dis. 2017 Feb 17;12(1):37. doi: 10.1186/s13023-017-0571-y.'}], 'seeAlsoLinks': [{'url': 'http://www.renape-online.fr/', 'label': 'Related Info'}, {'url': 'https://epidemiologie-france.aviesan.fr/fr/epidemiologie-france/fiches/registre-national-des-tumeurs-rares-du-peritoine', 'label': 'Related Info'}, {'url': 'http://www.e-cancer.fr/Professionnels-de-sante/L-organisation-de-l-offre-de-soins/Prise-en-charge-des-cancers-rares/Une-organisation-en-centres-experts', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Despite advances in the management of and changes in clinical practice, little is known about the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies patients in France.\n\nIn order to better understand the characteristics of rare peritoneal surface malignancies and to evaluate treatment strategies, the RENAPE registry aims at the collection of data from patients presenting with a rare peritoneal surface malignancy in France. Data will be entered prospectively in a specifically designed and secured web database.\n\nAll RENAPE's centres and physicians are invited to register patients with a rare peritoneal surface malignancy diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focusing on types of rare peritoneal surface malignancies, treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing to the better understanding of these rare cancers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are eligible if they have a histologically proven rare peritoneal surface malignancy.\n\nExclusion Criteria:\n\n* Histological diagnostic of peritoneal surface malignancy not confirmed\n* Expected clinical follow up data not available'}, 'identificationModule': {'nctId': 'NCT02834169', 'acronym': 'RENAPE', 'briefTitle': 'French National Registry of Rare Peritoneal Surface Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry)', 'orgStudyIdInfo': {'id': '69HCL16_0406'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pseudomyxoma peritonei', 'description': 'Data from pseudomyxoma peritonei cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}, {'label': 'peritoneal mesothelioma', 'description': 'Data from peritoneal mesothelioma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}, {'label': 'desmoplastic small round cell tumor', 'description': 'Data from desmoplastic small round cell tumor cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}, {'label': 'psammocarcinoma', 'description': 'Data from primary peritoneal serous carcinoma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}, {'label': 'primary peritoneal serous carcinoma', 'description': 'Data from primary peritoneal serous carcinoma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}, {'label': 'diffuse peritoneal leiomyomatosis', 'description': 'Data from diffuse peritoneal leiomyomatosis cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}, {'label': 'appendiceal mucinous neoplasms', 'description': 'Data from appendiceal mucinous neoplasms cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).', 'interventionNames': ['Other: Non interventional']}], 'interventions': [{'name': 'Non interventional', 'type': 'OTHER', 'description': 'Data collection', 'armGroupLabels': ['appendiceal mucinous neoplasms', 'desmoplastic small round cell tumor', 'diffuse peritoneal leiomyomatosis', 'peritoneal mesothelioma', 'primary peritoneal serous carcinoma', 'psammocarcinoma', 'pseudomyxoma peritonei']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest - Paul Papin", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'AP-HP Louis MOURIER', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'CHU A. Michallon', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital La Timône', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut du Cancer Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': "CHU L'Archet II", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP St Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP La Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hôpîtal Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet,', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': 'ROUEN', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut Cancérologie de l'Ouest - René Gauducheau", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHRU Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'François-Noël GILLY, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}