Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-01 @ 9:06 AM
Study NCT ID:
NCT05433935
Status:
RECRUITING
Last Update Posted:
2023-01-27
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The fresh blood, urine, feces and saliva of each patient will be collected during the surveillance. The samples of each patient will be collected at the following time points: 1) at diagnosis time of IPMN; 2) every 6 months during surveillance until malignant transformation. If patients receive surgical resection for targeted lesions, surgical specimens will also be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of IPMN malignant transformation', 'timeFrame': 'Up to 10 years'}], 'secondaryOutcomes': [{'measure': 'the probability of IPMN malignant transformation', 'timeFrame': 'Up to 10 years'}, {'measure': 'rates of surgical resection', 'timeFrame': 'Up to 10 years'}, {'measure': 'survival after surgery', 'timeFrame': 'Up to 10-15 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intraductal papillary mucinous neoplasm', 'biomarkers', 'prospective cohort'], 'conditions': ['Intraductal Papillary Mucinous Neoplasm']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.', 'detailedDescription': 'This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ought to meet all inclusion and exclusion criteria. In addition, the patient of the prospective cohort should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent of the prospective cohort should be obtained from the patient prior to enrollment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically diagnosed as IPMN;\n* without other malignant tumor;\n* agree to sign informed consent.\n\nExclusion Criteria:\n\n* with mental disorders which can affect cognition and cooperation;\n* with serious blood diseases or taking drugs that can affect peripheral blood'}, 'identificationModule': {'nctId': 'NCT05433935', 'briefTitle': 'Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas', 'orgStudyIdInfo': {'id': 'PCIPMN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective IPMN cohort', 'description': 'Multi-omics analysis of 5000 prospectively collected samples.', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'This is an observational study.', 'armGroupLabels': ['Prospective IPMN cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhang', 'role': 'CONTACT', 'phone': '13858108798'}], 'facility': 'the First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Tingbo Liang, PhD', 'role': 'CONTACT', 'email': 'liangtingbo@zju.edu.cn', 'phone': '+86 19941463683'}], 'overallOfficials': [{'name': 'Tingbo Liang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'Meng Chao Hepatobiliary Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Huizhou Municipal Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The chairman of the First Affiliated Hospital of Zhejiang', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}