Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 9:59 PM
Study NCT ID:
NCT05234450
Status:
UNKNOWN
Last Update Posted:
2022-02-10
First Post:
2022-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer of Pancreas', 'Neuroendocrine Tumors', 'Carcinoma', 'Neuroendocrine'], 'conditions': ['Cancer of Pancreas']}, 'descriptionModule': {'briefSummary': 'In this work, the investigators count through the integrated multi-omics analysis to identify different tumor subgroups in pancreatic neuroendocrine tumors and carcinomas regardless of their grade and stage. To achieve this, they will resort to the use of next-generation sequencing approaches (RNAseq, then use of MCP Counter for the absolute quantification of the eight populations of immune cells in the tumor microenvironment), alterations in epigenetics with study of the methylome by MeDIP, ChIPseq, telomere (ALT) study, as well as correlation with peripheral blood neutrophil to lymphocyte ratio and immunohistochemistry data such as Ki67, p53, Rb, DAXX, ATRX, PDL1, immune cell labeling. This will be done on frozen or paraffin material. This work will provide a more complete biological picture of pancreatic neuroendocrine tumors and carcinomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (≥18 years old) with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patient (≥18 years old)\n* Subject with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas\n* Subject with tumors or neuroendocrine carcinoma of the pancreas regardless of the stage of the disease\n* Supported at the University Hospitals of Strasbourg between 01/01/2008 and 01/09/2019\n* Near therapeutic blood count available (less than 6 months)\n* Availability of frozen and/or paraffin tumor material\n* Patients who have already given their consent for their biological resources to be kept at the CRB or in the anatomopathology department of the HUS, and subsequently reused, as well as the anonymous data associated with them, for scientific research purposes.\n\nExclusion criteria:\n\n* Opposition of the patient to participate in the study\n* Diagnosis other than pancreatic neuroendocrine tumor\n* Biological tissue from a patient who does not meet all the inclusion criteria\n* Impossibility of giving informed information to the subject\n* Patient under judicial protection En savoir plus sur ce texte sourceVous devez indiquer le texte source pour obtenir des informations supplémentaires Envoyer des commentaires Panneaux latéraux'}, 'identificationModule': {'nctId': 'NCT05234450', 'acronym': 'Camune', 'briefTitle': 'Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas', 'orgStudyIdInfo': {'id': '7561'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'CONTACT', 'email': 'malouf.gabriel@chru-strasbourg.fr', 'phone': '33 3 88 11 51 41'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}, {'name': 'Gabriel MALOUF, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Véronique DEBIEN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François SEVERAC, Statistician', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Oncologie - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'CONTACT', 'email': 'malouf.gabriel@chru-strasbourg.fr', 'phone': '33 3 88 11 51 41'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}], 'overallOfficials': [{'name': 'Gabriel MALOUF, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Oncologie - CHU de Strasbourg - France"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}