Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-11 @ 10:39 AM
Study NCT ID:
NCT05141656
Status:
UNKNOWN
Last Update Posted:
2021-12-02
First Post:
2021-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-20', 'studyFirstSubmitDate': '2021-11-20', 'studyFirstSubmitQcDate': '2021-11-20', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': '5 years', 'description': 'overall survival'}], 'secondaryOutcomes': [{'measure': 'DFS', 'timeFrame': '5 years', 'description': 'disease free survival'}, {'measure': 'PFS', 'timeFrame': '5 years', 'description': 'progress free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms']}, 'descriptionModule': {'briefSummary': "This study is a multi-center observational study. The start time for data collection is August 31, 2019. Patients who have been treated at our institution from August 31, 2019, who were diagnosed with pancreatic tumors on or before August 31, 2019 (diagnosed in our hospital or outside hospitals) would all meet the inclusion conditions of the study and be considered enrollment. Patients' baseline and treatment data will be collected under informed concent. The combination of medical big data governance and the leading technology of the big data platform uses real world data to improve the quality and efficiency of pancreatic tumor diagnosis, treatment and scientific research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as tumor of pancreas will all be considered for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18, both male and female;\n2. Patients with primary pancreatic tumor diagnosed by histology, cytology or imaging;\n3. Clinical or pathological staging is locally advanced or metastatic pancreatic tumor (newly diagnosed or after surgery and other treatments);\n4. You can accept or have not received surgery, chemotherapy, radiotherapy, local treatment or traditional Chinese medicine for tumors;\n5. The subject voluntarily joined the study and signed an informed consent form voluntarily.\n\nExclusion Criteria:\n\n1\\. Pancreatic tumors are evaluated as metastatic lesions, not primary tumors of the pancreas.'}, 'identificationModule': {'nctId': 'NCT05141656', 'briefTitle': "Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center", 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': "Construction and Evaluation of China's Advanced Pancreatic Tumor Big Data Center", 'orgStudyIdInfo': {'id': 'CPOG-CDPC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single arm', 'description': 'Patients diagnosed as pancreatic tumor will considered to be enrolled regardless of specific pathologic subtypes expect for metastasis of pancreas. Baseline data and treatment information will be collected under fully informed consent.', 'interventionNames': ['Other: No intervention will be considered in this study.']}], 'interventions': [{'name': 'No intervention will be considered in this study.', 'type': 'OTHER', 'description': 'No intervention will be considered in this study.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RenJiH', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}