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IRCT20230903059342N1 IRCT 2023-10-17 Kian Gen Azma Company Investigation of the safety and efficacy of the optimized measles virus vaccine in bladder tumor healing Phase 1 clinical trials of Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer 2023-09-23 anticipated 10 Complete https://irct.ir/trial/72410 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization is used so that the referents who have the conditions to enter the study are asked to choose between the numbers 1 and 2. If he chooses number 1, he enters the control group, and if he chooses number 2, he enters the new treatment group. 1 Bladder Cancer. Intervention 1: They include patients who receive the optimized measles vaccine product in addition to the standard treatment. Intervention 2: Control group: Patients who receive only standard treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ruhollah Dorostkar
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1619748194 +98 21 8817 0179 R.dorost@yahoo.com Bagheiat-allah University of Medical Sciences scientific Ruhollah Dorostkar
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1619748194 +98 21 8817 0179 R.dorost@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Bladder Cancer has been confirmed. The patient should be diagnosed by a urologist. It is not possible to remove the bladder for the patient. The age of the patient must be above 18 years The patient should not be pregnant. The patient's Karnofsky performance score (KPS) should be more than 50% (the patient is not disabled and does not need special assistance and care). The ability to understand and sign the consent form including the patient and one of these cases: the patient's spouse, parent. Ability to provide informed consent Be willing to comply with all required protocol steps, including providing biological samples and returning to the clinical study site for subsequent visits. Adequate performance status for treatment in the opinion of the enrolling urologist, including adequate hematological, liver, and renal function Must be willing to use contraceptive methods during the study. 18 years no limit Both Severe or life-threatening acute infection A history of not following the doctor's treatment orders Use of drugs that weaken the immune system Having diseases that disrupt the immune system History of organ transplantation Allergy to measles vaccine pregnancy Concomitant use of other investigational treatments Disease to other cancers such as skin that have not been fully treated. C67 Malignant neoplasm of bladder Treatment - Other Other They include patients who receive the optimized measles vaccine product in addition to the standard treatment. Control group: Patients who receive only standard treatment. Re-observation of bladder tumor by cystoscopy. Timepoint: Three months. Method of measurement: Cystoscopy examination of the bladder. Kian Gen Azma Company Approved 2023-08-15 FARHIKHTEGAN Hospital- Islamic Azad University Tehran, at the end of Sattari, north of University Square, in front of the Central Organization Tehran Tehran Iran (Islamic Republic of)