Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-28 @ 5:17 PM
Study NCT ID:
NCT06324058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094463', 'term': 'Transurethral Resection of Bladder'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-03-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor residual rate', 'timeFrame': '10-12 weeks after initial TURBt', 'description': '10-12 weeks after the initial TUR, Re-TUR or cystoscopy is performed on the original resection site, and a biopsy of the tissue at the original resection site is conducted to analyze and observe whether there is any tumor residue at the original tumor site.'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '2 years', 'description': 'Non-muscle invasive bladder cancer recurrence during follow-up'}, {'measure': 'Progression', 'timeFrame': '2 years', 'description': 'Muscle invasive bladder cancer recurrence during follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 18 and 85, male or female;\n2. Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");\n3. Good compliance and able to cooperate with observation;\n4. Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with severe infectious diseases such as bacteremia and toxemia;\n2. Patients with severe coagulation dysfunction;\n3. Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;\n4. Patients with other concurrent malignancies;\n5. Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;\n6. Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);\n7. Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;\n8. Pregnant or breastfeeding women;\n9. Other situations assessed by researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structure, mental or psychological disorders.'}, 'identificationModule': {'nctId': 'NCT06324058', 'briefTitle': 'Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC', 'orgStudyIdInfo': {'id': 'Huashan_H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoablation group', 'description': 'Transurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site.', 'interventionNames': ['Procedure: Transurethral cryoablation', 'Procedure: Transurethral resection of bladder tumor', 'Drug: Bcg Intravesical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Transurethral resection of bladder tumor, conventional BCG instillation after surgery', 'interventionNames': ['Procedure: Transurethral resection of bladder tumor', 'Drug: Bcg Intravesical']}], 'interventions': [{'name': 'Transurethral cryoablation', 'type': 'PROCEDURE', 'description': 'Using an intracavitary cryoablation balloon, cryoablation is performed on the wound surface after tumor resection. The wound surface is frozen for 2 rounds, with each round lasting 3 minutes, to fully cover the wound surface.', 'armGroupLabels': ['Cryoablation group']}, {'name': 'Transurethral resection of bladder tumor', 'type': 'PROCEDURE', 'otherNames': ['TURBt'], 'description': 'Resection of bladder tumor using resectoscopy, which is a standard procedure to treat non-muscle invasive bladder cancer', 'armGroupLabels': ['Control group', 'Cryoablation group']}, {'name': 'Bcg Intravesical', 'type': 'DRUG', 'description': 'Bacillus Calmette-Guerin instillation of bladder after surgery according to the NCCN bladder cancer guidelines. At least 6 weeks induction instillation is required for high-risk NMIBC patients. At least 1 year maintenance instillation is recommended.', 'armGroupLabels': ['Control group', 'Cryoablation group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shenghua Liu, Dr.', 'role': 'CONTACT', 'email': '08301010098@fudan.edu.cn', 'phone': '+8618101881202'}], 'overallOfficials': [{'name': 'Haowen Jiang, Pro.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haowen Jiang', 'investigatorAffiliation': 'Huashan Hospital'}}}}