Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 4:47 PM
Study NCT ID:
NCT04243057
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-24', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RFSR', 'timeFrame': '3 years', 'description': 'RFSR-Recurrence Free Survival Rate'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '3 years', 'description': 'OS-Overall Survival'}, {'measure': 'RFS', 'timeFrame': '3 years', 'description': 'RFS-Recurrence Free Survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, two-way, non-intervention study. the main purpose: Understand the current status of diagnosis and treatment of cholangiocarcinoma patients in China and observe the effect of different treatment options on patient recurrence and long-term survival\n\nSecondary purpose:\n\n1. Exploring the actual clinical treatment situation and its compliance with the existing diagnosis and treatment of bile duct cancer\n2. Exploring the establishment of clinical research standard fields and standards for diagnosis and treatment of bile duct cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from 21 hospitals limit:5000', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. above the age of 18 years old, male or female\n2. clinical diagnosis of patients with cholangiocarcinoma\n3. Child-Pugh classification of A, B\n4. Eastern Cooperative Oncology Group scoring system (ECOG) score of 0-2 points\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04243057', 'briefTitle': 'Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study', 'orgStudyIdInfo': {'id': 'RWS-BTCH-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '102218', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JiaHong Dong, MD', 'role': 'CONTACT', 'email': 'dongjiahong@mail.tsinghua.edu.cn', 'phone': '01056118763'}], 'facility': 'Beijing Tsinghua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaobin Feng, MD', 'role': 'CONTACT', 'email': 'fengxiaobin200708@aliyun.com', 'phone': '+86 16601111975'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive President of Beijing Tsinghua Changgung Hospital', 'investigatorFullName': 'Dong Jiahong', 'investigatorAffiliation': 'Beijing Tsinghua Chang Gung Hospital'}}}}