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Bladder Cancer clinical trials

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NCT ID: NCT06469229 Not yet recruiting - Bladder Cancer Clinical Trials

Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

Start date: July 1, 2024
Phase:
Study type: Observational

Background Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. Objectives To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC in patients with hematuria, using standard clinical and pathological diagnoses as the gold standard. We also aim to investigate the association between preoperative urine DNA methylation status and prognosis in UC patients. For non-UC patients: Follow up for one year to assess the risk of UC development based on preoperative urine DNA methylation status. Sample Size Calculation Expected sensitivity: 86% Expected specificity: 90% Significance level (Alpha): 0.05 Total participants needed: 1053 (adjusted for 5% dropout rate, 1109 participants will be recruited). Study Procedure Enrollment and Sample Collection: Screen patients, obtain consent, collect urine samples. Blinding and Testing: Blinded sample processing and DNA methylation testing. Unblinding and Analysis: Statistical analysis of sensitivity and specificity. Reporting: Compilation and consolidation of clinical trial reports. We anticipate that urine DNA methylation testing will show high sensitivity and specificity for UC diagnosis in patients with hematuria, providing valuable non-invasive diagnostic information and improving patient outcomes.

NCT ID: NCT06465069 Not yet recruiting - Prostate Cancer Clinical Trials

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

NEXUS-01
Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

NCT ID: NCT06447064 Recruiting - Ovarian Cancer Clinical Trials

Cancer Loyalty Card Study 2 (CLOCS-2)

(CLOCS-2)
Start date: April 29, 2024
Phase:
Study type: Observational

Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working. Therefore, early diagnosis is the most important way to improve cancer outcomes. Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person. The major reasons for not presenting to the GP with symptoms such as these are "not wanting to waste the GP's time" and normalisation of these symptoms. The persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician. RATIONALE FOR CURRENT STUDY An early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor. Information about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.

NCT ID: NCT06443944 Available - Bladder Cancer Clinical Trials

An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

Start date: n/a
Phase:
Study type: Expanded Access

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG.

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: NCT06427291 Recruiting - Bladder Cancer Clinical Trials

Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients

Start date: September 21, 2023
Phase: Phase 1
Study type: Interventional

This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC)

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: NCT06416319 Recruiting - Bladder Cancer Clinical Trials

Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)

PreAct
Start date: March 14, 2023
Phase: N/A
Study type: Interventional

A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.