Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT06381895
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumour-infiltrating lymphocytes (TIL)', 'timeFrame': '1 year', 'description': 'TILs were evaluated using paraffin-embedded tumour tissue samples stained with H\\&E according to established protocols.'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 year', 'description': 'We obtain this data through telephone follow-up and evaluate it according to the date of surgery'}, {'measure': 'cancer-specific survival', 'timeFrame': '1 year', 'description': 'We obtain this data through telephone follow-up and evaluate it according to the date of surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer', 'Radiomics', 'Immunotherapy']}, 'referencesModule': {'references': [{'pmid': '40053821', 'type': 'DERIVED', 'citation': 'Chen K, Li X, Liu L, Wang B, Liang W, Chen J, Gao M, Huang X, Liu B, Sun X, Yang T, Zhao X, He W, Luo Y, Huang J, Lin T, Zhong W. Correlation of noninvasive imaging of tumour-infiltrating lymphocytes with survival and BCG immunotherapy response in patients with bladder cancer: a multicentre cohort study. Int J Surg. 2025 Jan 1;111(1):920-931. doi: 10.1097/JS9.0000000000001999.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically confirmed primary bladder cancers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age;\n2. Performing TURB-t or RC during 2010-2022;\n3. The primary lesion was located in the bladder, and the pathological diagnosis was urothelial carcinoma;\n4. Complete clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records;\n\nExclusion Criteria:\n\n1. Patients with distant metastasis;\n2. Combined with other malignant tumors or malignant tumor treatment history\n3. Malignant tumors of upper urinary tract;\n4. Clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records were missing;\n5. Other situations in which the researcher considers it inappropriate to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06381895', 'briefTitle': 'The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer', 'nctIdAliases': ['NCT06442839'], 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer', 'orgStudyIdInfo': {'id': 'SYSKY-2023-467-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Sun Yat-sen Memorial Hospital cohort'}, {'label': '2', 'description': 'Third Affiliated Hospital of Sun Yat-sen University cohort'}, {'label': '3', 'description': 'Sun Yat-sen University Cancer Center cohort'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Liushan Ou', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Ethics Committee, Sun Yat-sen Memorial Hospital, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}