Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 10:05 PM
Study NCT ID:
NCT05824403
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAncreatic Disease Cohort of TOuLouse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples and tissues'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic tools', 'timeFrame': '3 years after the first inclusion', 'description': 'To develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies'}], 'secondaryOutcomes': [{'measure': 'New targets', 'timeFrame': '3 years after the first inclusion', 'description': 'To identify new screening targets'}, {'measure': 'Improvement of management', 'timeFrame': '3 years after the first inclusion', 'description': 'To improve the management of cystic lesions or Chronic pancreatitis on the decision of therapeutic management'}, {'measure': 'Microbiota', 'timeFrame': '3 years after the first inclusion', 'description': 'Study of the microbiota of pancreatic diseases'}, {'measure': 'Clinical data access', 'timeFrame': '3 years after the first inclusion', 'description': 'To make available to the scientific community quality material with associated clinical data also of quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic cyst', 'Acute pancreatitis', 'chronic pancreatitis', 'Intra Pancreatic Mucinous Neoplasia', 'diagnosis'], 'conditions': ['Pancreatic Diseases']}, 'referencesModule': {'references': [{'pmid': '38853244', 'type': 'DERIVED', 'citation': 'Bardol T, Dujon AM, Taly V, Dunyach-Remy C, Lavigne JP, Costa-Silva B, Kurma K, Eslami-S Z, Cayrefourcq L, Canivet C, Muscari F, Bournet B, Alix-Panabieres C. Early detection of pancreatic cancer by liquid biopsy "PANLIPSY": a french nation-wide study project. BMC Cancer. 2024 Jun 10;24(1):709. doi: 10.1186/s12885-024-12463-8.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.', 'detailedDescription': 'This collection focuses on pathology of the pancreas requiring specific investigations or management for diagnosis or treatment. Pancreatic pathologies can be classified as malignant, potentially malignant or benign tumors. These can be solid or cystic. There is an inflammatory attack on the pancreas, generating acute pancreatitis in the acute period, if the inflammatory manifestations persist, chronic pancreatitis will develop. Some lesions may be at risk of malignancy during their evolution, it is therefore necessary to improve the performance of monitoring and diagnostic tools in order to adapt the management of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pancreatic disease', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inflammatory or cystic exocrine pancreatic pathology\n* Patient able to read and understand the information leaflet\n* Patients who have agreed to participate in the study and have signed the free and informed consent\n* Patients affiliated to a social security system (including AME)\n\nExclusion Criteria:\n\n* Patient with pancreatic cancer pathology\n* Patients with active cancer, whatever the origin\n* Pregnant or breastfeeding patients\n* Patients under legal protection, guardianship or trusteeship'}, 'identificationModule': {'nctId': 'NCT05824403', 'acronym': 'PACTOL', 'briefTitle': 'PAncreatic Disease Cohort of TOuLouse', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'PAncreatic Disease Cohort of TOuLouse', 'orgStudyIdInfo': {'id': 'RC31/22/0530'}}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Barbara BOURNET, MD', 'role': 'CONTACT', 'email': 'bournet.b@chu-toulouse.fr', 'phone': '0561323235'}, {'name': 'Adrian CULETTO, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karl BARANGE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Louis BUSCAIL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabrice MUSCARI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlotte MAULAT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas CARRERE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rangueil hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Barbara BOURNET, MD', 'role': 'CONTACT', 'email': 'bournet.b@chu-toulouse.fr', 'phone': '0561323235', 'phoneExt': '+33'}, {'name': 'Cindy CANIVET', 'role': 'CONTACT', 'email': 'canivet.c@chu-toulouse.fr', 'phone': '05 61 32 20 48'}], 'overallOfficials': [{'name': 'Barbara BOURNET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}