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IRCT20220302054165N1 IRCT 2022-07-02 Shahid Beheshti University of Medical Sciences Efficacy and safety of modify maintenance instillation Bacillus- calmette-guerin (BCG) in bladder cancer Efficacy and safety evaluation of modify maintenance instillation Bacillus- calmette-guerin (BCG) in , with stage Ta high grade and/or multiple and/or large and T1 bladder cancer 2013-05-22 anticipated 64 Complete https://irct.ir/trial/62262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: This prospective randomized clinical trial study, according to the sample size obtained, 64 patients with non-muscle invasive bladder cancer referred to Labbafinejad Hospital (Tehran-Iran)who met the inclusion criteria were randomly divided into two groups of 32 patients. All patients in the study were given an intravesical BCG instillation one month after transurethral resection of tumor. Based on the table of random numbers generated by random allocation software in regard to simple random allocation with principle analyzer assigned patients to a randomly administered BCG instillation was given to a group of randomly selected patients for up to six months (intervention group) and the other group that received only the induced dose (control group). STATA software and RALLOC command are used to assign two groups of random numbers to two treatment groups, Blinding description: The patient does not know which group he or she belongs to, and the researcher , outcome assessor and the data analyst do not know which group they are evaluating. Participants, researchers, and outcome assessors are unaware of the allocation of study groups. Concealment and splitting into random groups is done by the clinical caregiver. 3 Bladder Cancer. Intervention 1: Intervention group: A group of randomly selected patients received an intravesical injection of Bacillus-Calmette-Guerin (BCG) every week for up to 6 weeks and then a monthly intravesical injection of BCG Continues until it lasts six months. A vial of BCG made in Iran and Pasteur Pharmaceutical Company is suspended in 50 cc of saline without preservative and inserted into the bladder with a catheter and stays in place for up to two hours. Intervention 2: Control group: A group of randomly selected patients receive an induced dose of bacillus-Calmette-Guerin (BCG) intravesical every week for up to 6 weeks. A vial of BCG made in Iran and Pasteur Pharmaceutical Company is suspended in 50 cc of saline without preservative and inserted to the bladder with a catheter and stays in position for up to two hours. Yes - There is a plan to make this available What will be shared: The personal data of the study participants and its main outcome will be shared after the individuals are not identified. When: After final report : September 2022 To whom: - Urology and Nephrology Research Center - Researchers working in academic and scientific institutions Conditions: Similar research projects Where to obtain: Urology and Nephrology Research Center How to obtain: According to the rules of the Urology and Nephrology Research Center Comments:
public Nasser Shakhssalim
No.44(103), Boostan 9 Alley , Pasdaran Street
Tehran Iran (Islamic Republic of) 1666668111 +98 21 2277 0954 shakhssalim@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Nasser Shakhssalim
No.44(103), Boostan 9 Alley , Pasdaran Street
Tehran Iran (Islamic Republic of) 1666668111 +98 21 2277 0954 shakhssalim@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Both 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. C67 Malignant neoplasm of bladder Prevention Prevention Intervention group: A group of randomly selected patients received an intravesical injection of Bacillus-Calmette-Guerin (BCG) every week for up to 6 weeks and then a monthly intravesical injection of BCG Continues until it lasts six months. A vial of BCG made in Iran and Pasteur Pharmaceutical Company is suspended in 50 cc of saline without preservative and inserted into the bladder with a catheter and stays in place for up to two hours. Control group: A group of randomly selected patients receive an induced dose of bacillus-Calmette-Guerin (BCG) intravesical every week for up to 6 weeks. A vial of BCG made in Iran and Pasteur Pharmaceutical Company is suspended in 50 cc of saline without preservative and inserted to the bladder with a catheter and stays in position for up to two hours. 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. 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. Urology and Nephrology Research Center Approved 2013-03-12 Ethics Committee of Urology and Nephrology Research Center, Shahid Beheshty University of Medical Sc No.44(103), Boostan 9 Alley , Pasdaran Street ,Tehran Tehran Tehran Iran (Islamic Republic of)