Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

All Drugs and Chemicals

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

* Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I
* Freeze-dried powder for bladder instillation

* Standard of Care
* Bacillus Calmette-Guérin (BCG): Strain TICE
* Freeze-dried powder for bladder instillation

* Induction: 80 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

Bacillus Calmette-Guerin: Strain Russian BCG-I

* Induction: 50 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

Bacillus Calmette-Guerin: Strain TICE

Jalees Farhan

Taniya Mann

Alexandre R Zlotta, MD

Girish S Kulkarni, MD

The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.

This study is a randomized, active control, double-blind clinical trial aimed at demonstrating non - inferiority of VERITY-BCG to OncoTICE, the current standard of care, with respect to two-year Recurrence Free Survival (RFS) rates in NMIBC BCG - naïve patients that are at high risk for recurrence (defined as \>50%).

• Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)

A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.

Incidence of treatment-emergent AEs and SAEs defined according to the CTCAE v5.0;

Number of subjects discontinuing study drug due to AEs

Usage of concomitant medications over time.

Cumulative Recurrence Free Survival (RFS) at 24 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Cumulative Recurrence Free Survival (RFS) at 36 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

Progression Free Survival (PFS) at 24 months as estimated using the Kaplan - Meier estimator of the survival function.

Progression Free Survival (PFS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

Overall Survival (OS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

Change in Quality of Life as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for NMIBC (EORTC-QLQ-NMIBC24) over 36 months.

The EORTC QLQ-NMIBC24 is a 24-item self-administered questionnaire that measures health-related quality of life in patients with intermediate to high-risk NMIBC. Items are ranked by the patient from 1 to 4 indicating the extent to which they have experienced those symptoms or problems. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

- High Score is equivalent to more problems, except for items on sexual function and sexual enjoyment for which a high score is interpreted as better function.

Change in functioning and symptom status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for Cancer Patients (EORTC-QLQ-C30) over 36 months.

The EORTC QLQ-C30 consists of 30 items and measures Health Related Quality of Life as well as presence of symptoms across all cancer types. The QLQ-C30 includes nine multi-item scales:

* 5 functional scales (physical, role, cognitive, emotional, and social)
* 3 symptom scales (fatigue, pain, and nausea and vomiting);
* A global health and quality-of-life scale\*
* Several single-item symptom measures

  28 Items are ranked 1 to 4. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

  \*2 items are ranked 1 to 7. 1=Very Poor, 7 = Excellent.

High score = More symptoms or worse problems

\*High Score = Better overall health or Quality of life.

Verity Pharmaceuticals Inc.

Behaviors and Mental Disorders

Carcinoma in Situ

Non-Muscle Invasive Bladder Neoplasms

Quality of Life

Patients with non-muscle invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES

Francesco Montorsi, MD

Giusy Burgio, MSc

A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.

Each patient will be followed for approximately 10 years starting from the date of surgery. The patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the Urology Department. The data for each patient will then be transferred to the database itself. The data collected will be handled follwing the most strict GCPs and privacy norms.

The data entered will concern:

* period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire
* hospitalization period with all its related data
* questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.

Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Endoscopic Resection Surgery for Bladder Cancer (TURBK).

All patients, before underwent endoscopic resection surgery, receive a diary in which we ask a detailed clinical history of the patient with their symptoms, diagnosis and previous urological e non urological treatments performed before the operation. A detailed intraoperative, postoperative and follow-up clinical history

Through the collection of a detailed clinical history of the patient in which themselves report symptoms, diagnosis and previous urological and non-urological treatments and also through the medical record.

IRCCS San Raffaele

Professor

Disease Progression

Bladder tumor patients with high residual volume

Bladder tumor patients with low residual volume

Mehmet Caglar Cakici, M.D.

Nihat Karakoyunlu, Assoc.Prof.

Erdem Kısa, Assoc.Prof

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. Participants who underwent transurethral resection for bladder tumor will be included in the study. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression

Non-muscle invasive bladder cancer recurrence rate

Non-muscle invasive bladder cancer progression rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)	NCT05037279	Bladder Cancer Bladder Cancer ... Neoplasm Recurr... Urothelial Carc... Urothelial Carc... Non-Invasive Bl...	Bacillus Calmet... Bacillus Calmet...	18 Years -	Verity Pharmaceuticals Inc.
Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.	NCT06167356	Non Muscle Inva... Non-Muscle Inva... Non-Muscle Inva... Bladder Cancer Bladder Disease Bladder Neoplas... Bladder Urothel... Bladder Cancer ... Bladder Cancer ... Bladder Urothel... Bladder Urothel...		18 Years -	IRCCS San Raffaele
The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression	NCT04617743	Bladder Cancer ... Non-Invasive Bl...		18 Years -	Istanbul Medeniyet University
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)	NCT05037279	Bladder Cancer Bladder Cancer ... Neoplasm Recurr... Urothelial Carc... Urothelial Carc... Non-Invasive Bl...	Bacillus Calmet... Bacillus Calmet...	18 Years -	Verity Pharmaceuticals Inc.
The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression	NCT04617743	Bladder Cancer ... Non-Invasive Bl...		18 Years -	Istanbul Medeniyet University

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