Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04134832
Status:
UNKNOWN
Last Update Posted:
2019-10-22
First Post:
2019-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007516', 'term': 'Adenoma, Islet Cell'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The survival will be evaluated by Kaplan Meier Method. The prognostic factors will be evaluated with univariate and multivariate analysis by Cox regression model.', 'timeFrame': 'The participant will be followed-up for a maximum of 11 years, and 1 year at least.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic neuroendocrine tumors', 'Neutrophil-to-lymphocyte ratio'], 'conditions': ['Pancreatic Neuroendocrine Tumor']}, 'descriptionModule': {'briefSummary': 'Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas.\n\npNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma, with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease and covered in one of the participating centres between 01/01/2008 and 01/01/2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Major topic ((≥18 years)\n2. Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma\n3. Subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease.\n4. Subject covered in one of the participating centres between 01/01/2008 and 01/01/2019\n5. Have a pre-therapeutic biological check-up\n6. Subject who has not expressed opposition to the use of his or her data for research purposes\n\nExclusion criteria:\n\n1. Subject who expressed opposition to participate in the study\n2. Lack of histological data\n3. Minor subject\n4. Patient under the protection of justice\n5. Subject under guardianship or trusteeship'}, 'identificationModule': {'nctId': 'NCT04134832', 'briefTitle': 'Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region', 'orgStudyIdInfo': {'id': '7435'}}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'CONTACT', 'email': 'gabriel.malouf@chru-strasbourg.fr', 'phone': '33 3 88 11 62 22'}, {'name': 'Gabriel MALOUF, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Marc Limacher, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emmanuel Achille', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Louis-Marie Dourthe', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bernard Willemin', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stéphanie Husson', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meher Ben Abdelghani', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Véronique Debien', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service D'Hematologie Et D'Oncologie", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'CONTACT', 'email': 'gabriel.malouf@chru-strasbourg.fr', 'phone': '33 3 88 11 62 22'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}