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Urinary Bladder Neoplasms clinical trials

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NCT ID: NCT06287541 Recruiting - Clinical trials for Non Muscle Invasive Bladder Cancer

The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.

NCT ID: NCT06281691 Enrolling by invitation - Clinical trials for Urinary Bladder Neoplasms

GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit

Start date: April 28, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland.

NCT ID: NCT06281080 Not yet recruiting - Bladder Cancer Clinical Trials

First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.

NCT ID: NCT06263153 Not yet recruiting - Clinical trials for Bladder Urothelial Carcinoma

Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.

NCT ID: NCT06257017 Recruiting - Clinical trials for Muscle-Invasive Bladder Carcinoma

Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial

Start date: February 2, 2024
Phase: Phase 2
Study type: Interventional

Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.

NCT ID: NCT06255964 Not yet recruiting - Bladder Cancer Clinical Trials

A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer

Start date: February 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.

NCT ID: NCT06253845 Recruiting - Clinical trials for Non-muscle Invasive Bladder Cancer

Study of CG0070 After Transurethral Resection in Patients With IR NMIBC

Start date: January 29, 2024
Phase: Phase 1
Study type: Interventional

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

NCT ID: NCT06253091 Recruiting - Bladder Cancer Clinical Trials

Comparison of the Application of Robot-assisted Laparoscopic Pathways in Radical Cystectomy

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Traditional radical cystectomy (RC) is performed transabdominal. However, it often has high postoperative complications. There have been studies on extraperitoneal approach to reduce postoperative complications. Investigators divided participants underwent robot-assisted radical cystectomy into two groups (1:1) . One group of participants transabdominal, the other group extraperitoneal. The incidence of complications and PFS/OS at 3, and 5 years were compared.

NCT ID: NCT06245759 Recruiting - Bladder Cancer Clinical Trials

The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients

Start date: August 31, 2023
Phase:
Study type: Observational

Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development.

NCT ID: NCT06245603 Not yet recruiting - Clinical trials for Non-muscle Invasive Bladder Cancer

A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer

Hydeal Cyst
Start date: March 2024
Phase: N/A
Study type: Interventional

Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria. Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study. The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS. BCG or MMC will be started within 1-2 weeks from randomization (within 4-6 weeks after TURB). BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment. 48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation. BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation. After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed. After 6 and 12 weeks from instillation therapy end, a control visit will be made. A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.