Efficacy and safety of modify maintenance instillation Bacillus- calmette-guerin (BCG) in bladder cancer
Phase 3
- Conditions
- Bladder Cancer.Malignant neoplasm of bladder
- Registration Number
- IRCT20220302054165N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Patients with non-muscle invasive bladder cancer (stage Ta and T1).
Have a history of transurethral resection of tumor (TURT) one month before Bacillus-calmette-guerin (BCG) therapy.
Have no previous history of BCG instillation.
Do not have contraindications to BCG instillation.
Exclusion Criteria
Patients with muscle invasive bladder cancer
Have a history of transurethral resection of tumor (TURT) more than one month before Bacillus-calmette-guerin (BCG) therapy.
Have previous history of BCG instillation.
Have contraindications to BCG instillation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acceptance rate by patients. Timepoint: After induction dose and then every month for up to 6 months. Method of measurement: Visit and follow up the patients.;Complications. Timepoint: After induction dose and then every month for up to 6 months. Method of measurement: Patient symptoms and complaints.
- Secondary Outcome Measures
Name Time Method Recurrence rate. Timepoint: Every 3 months to 2 years. Method of measurement: laboratory tests , cytology and cystoscopy.;Progress rate. Timepoint: Every 3 months to 2 years. Method of measurement: laboratory tests , cytology and cystoscopy.