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Bladder Cancer clinical trials

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NCT ID: NCT06440018 Not yet recruiting - Breast Cancer Clinical Trials

INSPIRE: A Multi-Cancer Early Detection Study

INSPIRE
Start date: June 20, 2024
Phase:
Study type: Observational

This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis

NCT ID: NCT06427993 Not yet recruiting - Bladder Cancer Clinical Trials

Urine DNA Methylation Detection for Hematuria Evaluation

Start date: June 15, 2024
Phase:
Study type: Observational

Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients. Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria. Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves. Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies.

NCT ID: NCT06427824 Not yet recruiting - Bladder Cancer Clinical Trials

Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy

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

This study focuses on providing an educational program for people/participants with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. They will also be asked to fill out questionnaires.

NCT ID: NCT06422312 Not yet recruiting - Bladder Cancer Clinical Trials

A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.

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

This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.

NCT ID: NCT06397040 Not yet recruiting - Quality of Life Clinical Trials

The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy

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

Following radical cystectomy for bladder cancer, nearly two-thirds of patients experience a complication and almost a third are readmitted. Thus, intensified monitoring of this vulnerable group represents an opportunity for improved quality of care in the post-operative setting. By gathering biomarkers passively and continuously, wearable activity monitors augment remote patient monitoring. Further, they facilitate the collection of patient-reported outcomes frequently. Despite the proven impact of remote monitoring on patient care, there is limited data on the feasibility and impact of employing this technology to trigger real-time provider assessment following cystectomy. The investigators plan to conduct a randomized control trial examining such. The intervention group of participants will receive continuous biomarker monitoring via FitBits and daily patient-reported outcome assessments via connected smartphones. Abnormalities in remote data will trigger automated alerts to providers. Providers will respond in real-time to these alerts and patients will receive education materials discussing preventative measures to mitigate the main risk factors for readmissions. The investigators will evaluate the feasibility of integrating this technology into the post-operative period, as well as the impact of real-time provider attention to abnormal remote data on patient-reported outcomes and rates of readmission. The investigators hypothesize that early assessment of and intervention on remote abnormalities will promote the use of outpatient or reduced intensity therapies, such as oral antibiotics or oral hydration, thus curtailing the severity of patient symptoms, intensity of complications, and need for hospitalizations. Ultimately, this trial builds upon prior research, applying patient-centered technology to improve the quality of care following cystectomy.

NCT ID: NCT06394570 Not yet recruiting - Bladder Cancer Clinical Trials

Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer

STAR-EV
Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Level 0: EV treatment followed by RT to the bladder Level 1: EV treatment with RT starting on Cycle 2, Day 15 Level 2: EV treatment with RT starting on Cycle 1, Day 15 Following completion of EV+RT neoadjuvant therapy, all subjects will undergo surgery as part of routine care.

NCT ID: NCT06390111 Not yet recruiting - Bladder Cancer Clinical Trials

A Phase 4, Multi-center, Open Label Trial to Evaluate Efficacy of Retreatment With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose

ABLE-42
Start date: April 30, 2024
Phase: Phase 4
Study type: Interventional

In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered retreatment when entering the trial. Retreatment is justified at 3 months after first dose of nadofaragene firadenovec, since 3-months' follow-up scheme is the standard of care in high-risk NMIBC. Retreatment at month 3 is used in a trial investigating intravesical instillation of a IL 15 superagonist (nogapendekin alfa inbakicept [NAI], also known as N 803), and lead to a CR in 46% (11 of 24) of the subjects at month 6. Moreover, retreatment is a widely accepted concept in immuno-oncology and has been used in IFN α treatment of kidney cancer in the past. It is currently also used in an ongoing phase 3 trial investigating the efficacy of oncolytic virus (CG0070) in BCG-unresponsive NMIBC. In this trial, around one third of the subjects who did not respond to the first treatment of CG0070 achieved CR after retreatment at 3 months. Therefore, it is also expected that a retreatment with nadofaragene firadenovec would show a comparable response rate.

NCT ID: NCT06374914 Not yet recruiting - Bladder Cancer Clinical Trials

Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients

Start date: April 9, 2024
Phase:
Study type: Observational

Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients.

NCT ID: NCT06364904 Not yet recruiting - Bladder Cancer Clinical Trials

An Phase III Study, Multicenter,Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Start date: April 15, 2024
Phase: Phase 3
Study type: Interventional

The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.

NCT ID: NCT06355518 Not yet recruiting - Bladder Cancer Clinical Trials

Pre-operative Immuno-Nutrition in Radical Cystectomy

INu-RC
Start date: April 2024
Phase: N/A
Study type: Interventional

This study will evaluate the effect of preoperative oral immunonutrition on postoperative complications in patients undergoing radical cystectomy for bladder cancer. Patients receiving preoperative immunonutrition will be compared to controls receiving a standard high-calorie, high-protein oral nutritional supplement.