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Urinary Bladder Neoplasms clinical trials

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NCT ID: NCT05236218 Recruiting - Surgery Clinical Trials

To Better Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC).

Start date: July 20, 2022
Phase:
Study type: Observational

Through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for MIBC. Our study consists of a discrete choice experiment (DCE): a type of questionnaire used to elicit preferences in the absence of data. DCEs are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. Participants undertaking our DCE questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".

NCT ID: NCT05232136 Recruiting - Clinical trials for Non-muscle-invasive Bladder Cancer

OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer

Start date: July 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ⅰb/Ⅱ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

NCT ID: NCT05226117 Recruiting - Clinical trials for Urothelial Carcinoma

Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer

Start date: November 29, 2021
Phase: Phase 2
Study type: Interventional

SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).

NCT ID: NCT05223491 Recruiting - Clinical trials for Non-muscle Invasive Bladder Cancer

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Start date: March 17, 2022
Phase: N/A
Study type: Interventional

Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty. Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed. Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022. Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.

NCT ID: NCT05220189 Recruiting - Bladder Cancer Clinical Trials

PENK Methylation Test for Detecting Bladder Cancer

Start date: February 3, 2022
Phase:
Study type: Observational

The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® Bladder Cancer test for bladder cancer among patients with hematuria by comparing it to the results of cystoscopy examinations. The second objective is to compare the clinical performance of EarlyTect® Bladder Cancer test with a NMP22 test and urine cytology test with respect to bladder cancer. By histopathological examination, lesions identified during cystoscopy will be confirmed as malignant or non-malignant by histological examination.

NCT ID: NCT05220124 Recruiting - Clinical trials for Bladder Urothelial Carcinoma

A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma

Start date: January 5, 2022
Phase: Phase 4
Study type: Interventional

A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.

NCT ID: NCT05204199 Recruiting - Bladder Cancer Clinical Trials

Role of Microbiome in BCG Responsiveness Prediction

SILENTEMPIRE
Start date: February 22, 2022
Phase:
Study type: Observational

Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration. Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.

NCT ID: NCT05204186 Recruiting - Bladder Cancer Clinical Trials

Impact of COMORBIDities After Radical Cystectomy Using a Predictive Method With Artificial Intelligence

COMORBID-AI
Start date: January 10, 2021
Phase:
Study type: Observational

Clinician and the multidisciplinary team meeting in oncologic urology (MMO) play a key-role in the decision making. An unexplained surgeon attributable variance, probably linked to the subjective "eyeball test" effect, was identified as a strongest factor underlying non-compliance with guide line recommendations in the management of bladder cancer. So high-quality studies that identify barriers and modulators (such as comorbidities) of provider-level adoption of guidelines and how comorbidities are associated in making therapeutic choice and their impact in bladder cancer specific survival and overall survival, are crucial. To identify patients at high risk of early death, and to improve specific guideline for treatment might be decisive. In order to assess survival, where mortality events compete, it will be more appropriate to compute a Cumulative Incidence Function (namely CIF). The investigators will compare outcomes across patient populations to obtain information to improve clinical decision-making. Such learning will be done through the use of neural networks or by applying population-based approaches, such as Genetic Algorithms (GA), Ant Colony Systems (ACS) and Particle Swarm Optimization (PSO), using as a four-stage based approach. First, the investigators propose a "pretopology space" in order to study a dynamic phenomenon. Second, the investigators recall that the K-means approach remains one of the most used approaches for classifying a set of elements (patients / persons / others) into K (disjunctive) clusters. Third, the investigators propose a learning pretopology space for enhancing the clustering. Such an approach can be assimilated in spirit to one applied with high success on deep learning. Fourth and last, the investigators propose a reactive method that is able to include some new elements or remove some contained elements

NCT ID: NCT05204108 Recruiting - Bladder Cancer Clinical Trials

Preoperative Detection of Muscle Invasion in Bladder Cancer With Contrast-enhanced Ultrasonography

Start date: April 1, 2020
Phase:
Study type: Observational

To evaluate the diagnostic accuracy of CEUS for the preoperative staging of bladder cancer, which would benefit the implementation of efficient therapeutic strategies.

NCT ID: NCT05203913 Recruiting - Clinical trials for Muscle-Invasive Bladder Carcinoma

Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer

CNN-BC
Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

In this phase II study, eligible patients will be treated with maximal tumor resection and then started treatment within 8 weeks. Chemotherapy, Nivolumab and radiotherapy (RT) will be started on day one. Chemotherapy will be administered weekly during radiotherapy. Radiotherapy will be performed from Monday to Friday for five weeks. Nivolumab will be administered for one year (13 infusions). Patients will have the complete tumour assessment by computed tomography scan (CT-scan) and cystoscopy up to 5 years after radiotherapy.