Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-02 @ 3:04 AM
Study NCT ID:
NCT06663735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Current Status of Diagnosis and Treatment of Uroepithelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '400 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describing the diagnosis and treatment patterns of patients with early versus advanced uroepithelial carcinoma in different grades of hospitals in Henan Province', 'timeFrame': 'up to the patients enrolled,an average of 1 year', 'description': 'To describe the similarities and differences between the way patients with early and advanced uroepithelial cancer are diagnosed and treated in different levels of hospitals in Henan Province and the current guidelines for uroepithelial cancer.'}], 'secondaryOutcomes': [{'measure': 'Comparison of differences in diagnosis and treatment patterns between patients with early-stage and advanced uroepithelial carcinoma in county hospitals and different consultation departments of the same hospital in Henan province', 'timeFrame': 'up to the patients enrolled,an average of 1 year', 'description': 'The main purpose of this study is to compare the differences between the diagnosis and treatment modalities and guidelines for early and advanced uroepithelial cancer patients in Henan Province in county hospitals. It also compares the differences in treatment modalities between different departments in the same level of hospitals.'}, {'measure': 'Describing the pathology as well as genetic testing of patients with uroepithelial carcinoma in different grades of hospitals in Henan province', 'timeFrame': 'up to the patients enrolled,an average of 1 year', 'description': '1. Proportion of different genes/proteins tested in patients with uroepithelial cancer (mutations in FGFR, HER2, HRR, ARID1A and CREBBP, TP53, CDKN2A and PD-L1 expression)\n2. Proportion of early and advanced uroepithelial cancer patients with high expression/mutations of different genes and use of targeted therapies'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Henan province', 'uroepithelial cancer', 'treatment'], 'conditions': ['Uroepithelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'A cross-sectional study describing the current status of diagnosis and treatment of uroepithelial cancer in hospitals of different grades in Henan Province', 'detailedDescription': 'Patients diagnosed with uroepithelial carcinoma attending multiple research center hospitals in Henan Province from January 1, 2023 to December 31, 2023 A questionnaire was used to collect and analyze the treatment patterns of patients with early versus advanced uroepithelial cancer in different levels of hospitals in Henan Province.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with uroepithelial carcinoma attending multiple research center hospitals in Henan Province from January 1, 2023-December 31, 2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years of age (at enrollment)\n* Histologically confirmed uroepithelial carcinoma\n* Patients with newly diagnosed or completed radical uroepithelial carcinoma in the early stages of uroepithelial cancer/advanced unresectable or with distant metastases of urothelial carcinoma\n* Complete medical history information\n\nExclusion Criteria:\n\n* Incomplete medical history and medical records'}, 'identificationModule': {'nctId': 'NCT06663735', 'briefTitle': 'Current Status of Diagnosis and Treatment of Uroepithelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xinxiang Medical College'}, 'officialTitle': 'A Cross-sectional Study Describing the Current Status of Diagnosis and Treatment of Uroepithelial Cancer in Hospitals of Different Grades in Henan Province', 'orgStudyIdInfo': {'id': 'CHASE010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnosis and management of patients with early stage resectable uroepithelial carcinoma', 'description': 'The study is a multicenter, non-interventional, observational cross-sectional study. It is planned to enroll patients with early stage resectable uroepithelial cancer in each study hospital in Henan Province. This is a cross-sectional study, and all patients will be anonymized for clinical data collection, and detailed information on patient demographic characteristics as well as medical and treatment history, hospitals at different stages of treatment, pathological test results, and medication regimens will be recorded at the beginning of enrollment.'}, {'label': 'Diagnosis and management of patients with advanced unresectable uroepithelial cancer', 'description': 'It is planned to enroll patients with advanced unresectable uroepithelial cancer in each study hospital in Henan Province. This is a cross-sectional study, and all patients will be anonymized for clinical data collection, and detailed information on patient demographic characteristics as well as medical and treatment history, hospitals at different stages of treatment, pathological test results, and medication regimens will be recorded at the beginning of enrollment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '453000', 'city': 'Kaifeng', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Zhiqiao Xu', 'role': 'CONTACT', 'email': '13503780918@qq.com', 'phone': '86+13503780918'}], 'facility': 'Kaifeng City Center Hospital', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'zip': '450000', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Baocai Zhang', 'role': 'CONTACT', 'email': '13007570235@qq.com', 'phone': '86+13007570235'}], 'facility': 'Luoyang Renda Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '450000', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Zhongyu Qu', 'role': 'CONTACT', 'email': '18538953067@qq.com', 'phone': '86+18538953067'}], 'facility': 'Nanyang City Center Hospital', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'zip': '450000', 'city': 'Puyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Xianfeng Du', 'role': 'CONTACT', 'email': '17657682939@qq.com', 'phone': '86+17657682939'}], 'facility': "Qingfeng County People's Hospital", 'geoPoint': {'lat': 35.75641, 'lon': 115.04363}}, {'zip': '453100', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Ping Lu, Professor', 'role': 'CONTACT', 'email': 'lupingdoctor@126.com', 'phone': '86+13598722864'}], 'facility': 'Department of Oncology', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453700', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Guangji Zhu', 'role': 'CONTACT', 'email': '18567382712@qq.com', 'phone': '86+18567382712'}], 'facility': "Hui County People's Hospital", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453700', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Kaituo Zhang', 'role': 'CONTACT', 'email': '19903925222@qq.com', 'phone': '86+19903925222'}], 'facility': "Jun County People's Hospital", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453700', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Jinfeng Chang', 'role': 'CONTACT', 'email': '13939278396@qq.com', 'phone': '86+13939278396'}], 'facility': "Qi County People's Hospital", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453700', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Dongquan Wang', 'role': 'CONTACT', 'email': '13523859806@qq.com', 'phone': '86+13523859806'}], 'facility': 'Xinxiang Allied Hospital', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453700', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Guifang Zhang', 'role': 'CONTACT', 'email': '15637359110@qq.com', 'phone': '86+15637359110'}], 'facility': 'Xinxiang Central Hospital', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Qingwei Wang', 'role': 'CONTACT', 'email': '756555706@qq.com', 'phone': '86+13838395053'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Ping Lu, Professor', 'role': 'CONTACT', 'email': 'lupingdoctor@126.com', 'phone': '86+13598722864'}, {'name': 'Yana Zhang, Phd.', 'role': 'CONTACT', 'phone': '86+15093230340'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xinxiang Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}