Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 3:52 AM
Study NCT ID:
NCT05593393
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2022-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077779', 'term': 'Pancreatic Intraductal Neoplasms'}], 'ancestors': [{'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019160', 'term': 'Endosonography'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Baseline sample includes 20ml blood sample, 1 oral flora swab and 1 stool sample.\n\nFollow-up samples include 10mL blood sample and remaining samples of pancreatic puncture tissue and/or cyst fluid during EUS'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The termination of the follow-up of IPMN patients, including death termination and recommended surgery termination.', 'timeFrame': '3 years', 'description': 'Patient died or was recommended for surgical treatment.'}], 'secondaryOutcomes': [{'measure': 'The new development of worrisome features or high-risk stigmata', 'timeFrame': '3 years', 'description': 'High-risk stigmata refers to obstructive jaundice, enhancing mural nodules or an associated solid component, and those with an MPD ≥10 mm. Worrisome features refer to acute pancreatitis, cyst size ≥30 mm, thickened/enhancing cyst wall, MPD measuring 5-9.9 mm, nonenhancing mural nodules, and abrupt change in MPD caliber with distal atrophy of the pancreatic gland.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IPMN', 'clinical outcomes', 'EUS'], 'conditions': ['IPMN, Pancreatic']}, 'descriptionModule': {'briefSummary': 'Study objective: To establish a long-term follow-up cohort of patients with IPMN, study the follow-up, clinical outcomes and prognostic factors of patients with IPMN, and provide a basis for clinical decisions and guidelines.\n\nStudy design: This is a real world, multicenter, prospective, observational cohort study', 'detailedDescription': 'Baseline assessment will be conducted on IPMN patients who meet the inclusion conditions and are included in the study with informed consent, including: ① demographic characteristics (such as age, gender, etc.); ② Clinical features (such as symptoms, complications, past history, family history, living/eating habits); ③ Characteristics of laboratory indicators (such as pancreatic function, liver enzyme, bile duct enzyme, CA199, CEA in blood; CA199, CEA in cystic fluid, etc.); ④ Imaging features \\* (such as multiple or single lesions, diameter of cyst, whether there are mural nodules, diameter of main pancreatic duct, etc.); ⑤ Endoscopic ultrasound (EUS) features \\* (such as: cyst location, echo, maximum diameter, whether the cyst wall is thickened, wall nodules, the connection between the cyst and the main pancreatic duct, laser confocal endoscopy features, etc.); ⑥ Pathological information (cytology of cystic fluid; cytological smear of cystic lesion puncture, histopathology); ⑥ Molecular characteristics of cyst fluid (such as proteomics/mass spectrometry, new biomarkers, next generation sequencing (NGS), flora characteristics, etc.); ⑦ Treatment information (such as current medication, whether to have received endoscopic treatment, etc.).\n\nThe follow-up contents include: outpatient follow-up (symptoms, laboratory indicators; keeping peripheral blood samples) every six months;, imaging follow-up (including enhanced pancreatic MR and EUS imaging; the first pancreatic MRI follow-up was conducted 6 months after enrollment to determine the stability of the lesions) at baseline and every 12 months thereafter.\n\nDuring the follow-up, if the patient died of various causes, the follow-up will be terminated; If enhanced nuclear magnetic resonance imaging or EUS imaging of the pancreas indicates worrisome features (WFs) or high-risk features (High risk stigmata, HRS), EUS-FNA ± nCLE should be performed (when performing EUS, perform contrast-enhanced ultrasonography on cystic lesions with mural nodules, and collect cystic fluid when puncturing some cystic lesions with sufficient volume).\n\nIf the cytological/histological pathological results of FNA indicate cancer or high grade dysplasia (HGD), or/and cystic fluid cytological results are positive, surgical treatment is recommended; If the FNA and cyst fluid cytology results are negative, the patients with WF will be followed up 6 months later, while the HRS patients will be followed up 3 months later (whether to accept EUS examination is decided jointly by the follow-up physician and the patient). It is suggested to review EUS-FNA ± nCLE according to the imaging results. If the patient was advised to receive surgical treatment due to IPMN, the follow-up was terminated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IPMN patients in Peking Union Medical College Hospital and other related research centers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: 18 years old or above;\n2. Diagnosis: Imaging examination showed the presence of intraductal papillary mucinous cystic tumor (IPMN) without high-risk features (including WF and HRS);\n3. The patient or family members can understand the study protocol, are willing to participate in the study, and provide written informed consent.\n\nExclusion Criteria:\n\n1. The patient's clinical, imaging and auxiliary examination characteristics conform to the surgical indications of the International Association of Pancreatic Diseases (IAP) 2018 guidelines, and the patient has no surgical contraindication;\n2. Previous history of pancreatic malignant tumor;\n3. There were the following worrisome features (WF) of IPMN found in the past examination: acute pancreatitis, cyst size ≥ 30mm, cyst wall thickening/strengthening, main pancreatic duct diameter of 5-9.9mm, non enhanced mural nodules, sudden change of main pancreatic duct diameter with distal pancreatic atrophy;\n4. The following high risk features of IPMN (HRS) were found in the past: obstructive jaundice, enhanced mural nodules or related solid components, and main pancreatic duct\\>10mm;\n5. The patient or family member could not understand the conditions and objectives of this study."}, 'identificationModule': {'nctId': 'NCT05593393', 'briefTitle': 'A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm', 'orgStudyIdInfo': {'id': 'K2378'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic ultrasound', 'type': 'DEVICE', 'description': 'The EUS follow-up will be conducted at baseline and every 12 months thereafter. For patients with new WF or HRS in the evaluation, the follow-up physician and the patient can jointly decide whether to perform EUS evaluation in the 6 or 3 month intensive follow-up.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xi Wu, M.D.', 'role': 'CONTACT', 'email': 'wxpumch@163.com', 'phone': '13683296860'}], 'overallOfficials': [{'name': 'Xi Wu, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Shengyu Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Yiran Su, MD candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Wu Xi', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}