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Urinary Bladder Neoplasms clinical trials

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NCT ID: NCT05406713 Recruiting - Clinical trials for Urothelial Carcinoma

Pembrolizumab in Muscle-invasive Bladder Cancer

Start date: July 13, 2022
Phase: Phase 2
Study type: Interventional

Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol. Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.

NCT ID: NCT05401279 Recruiting - Clinical trials for Urothelial Carcinoma Bladder

Bladder Sparing Treatment of Tislelizumab, Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

This is a phase II open label single-arm prospective study aiming to investigate the efficacy of PD-1 inhibitor Tislelizumab combined with conventional gemcitabine and cisplatin as bladder sparing treatment for patients with PD-L1 positive muscle invasive bladder carcinoma (T2-3N0M0).

NCT ID: NCT05397262 Recruiting - Bladder Cancer Clinical Trials

Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia

HyBla_RCT
Start date: March 29, 2017
Phase: N/A
Study type: Interventional

Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer

NCT ID: NCT05392634 Recruiting - Bladder Cancer Clinical Trials

Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery

MACS
Start date: February 2, 2022
Phase: Phase 3
Study type: Interventional

The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation. Research hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.

NCT ID: NCT05375903 Recruiting - Bladder Cancer Clinical Trials

A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

Start date: June 1, 2022
Phase: Phase 1
Study type: Interventional

This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.

NCT ID: NCT05347342 Recruiting - Bladder Cancer Clinical Trials

A Diagnostic for the Early Detection of Bladder Cancer

Start date: April 29, 2022
Phase:
Study type: Observational

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

NCT ID: NCT05337397 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Cancer

Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer

OPTIMA
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

Aim: To investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting. Background: Non-muscle invasive bladder cancer (NMIBC) is associated with a high yearly recurrence rate up to to 61%. Patients affected are therefore referred to long-term or even life-long follow-up, which burdens both patients and health care system. Recurrent tumours are most frequently treated with TURBT followed by adjuvant intravesical treatment. Repeat TURBT includes a risk of morbidity from the procedure itself and from general anaesthetics, which the procedure requires. Patients with NMIBC are generally elderly, multi-morbid, and as a result, they often show a poor tolerability of general anaesthetics. Thus, the need for non-surgical treatment modalities is imminent and continuous investigations are performed in the field including active surveillance, chemoresection and device-assisted intravesical chemotherapy. Laser ablation is a technique gaining attention in the treatment of NMIBC, based on the prospects of an outpatient treatment modality, which could prove TURBT and general anaesthesia unnecessary in select patients. Methods: The study will be conducted as a prospective feasibility study. Included patients will undergo outpatient laser ablation using the Olympus Soltive laser under local anaesthetics. Patients will be included from Aarhus University Hospital (Denmark), Fundació Puigvert (Spain), Motol University Hospital (Czech Republic) and Institut Universitaire du Cancer Toulouse Oncopole (France). Data will be reported to the eCRF in the online REDCap web application. The eCRF is stored on a secure server under the responsibility of the Department of Clinical medicine at Aarhus University in Denmark. REDCap is a secure web application for building and managing online surveys and databases. The Database will be in agreement with the laws and regulations of the Danish Data Protection Agency and EU regulations (GDPR). The sponsor will be overall responsible for the data entry in the eCRF, and the validity of the data collected at the specific sites. Each participant will be coded with a unique patient identifier to ensure pseudo anonymity. Perspectives: This study will be the first multinational study with focus on feasibility of outpatient laser ablation of large bladder tumours between 1-3 cm. Outpatient laser ablation of these large tumours has the potential to reduce the number of TURBTs per patient, thus easing the life of patients with non-muscle invasive bladder cancer, with fewer surgical procedures as well as reducing the overall treatment related costs for society. If thulium laser ablation proves effective, the treatment modality would be easily implemented and available based on the small size of the machinery.

NCT ID: NCT05337189 Recruiting - Bladder Cancer Clinical Trials

A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China

Start date: March 9, 2022
Phase:
Study type: Observational

The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).

NCT ID: NCT05334069 Recruiting - Melanoma Clinical Trials

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Start date: August 1, 2022
Phase:
Study type: Observational

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

NCT ID: NCT05332353 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Cancer

Machine Learning-Based Prediction of BCG Response in High-Risk Non-Muscle Invasive Bladder Cancer Patients

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

This prospective study aims at using Artificial intelligence to create a helpful unbiased machine learning-based model that predicts BCG unresponsiveness in high risk BCG-naïve NMIBC patients incorporating all potential clinico-pathological, radiological and/or molecular prognostic factors.