Active clinical trials for "Urinary Bladder Neoplasms"

This study is aimed to develop a genome-based platform to predict patients who can achieve bladder preservation after neoadjuvant treatment. The main treatments for invasive bladder cancer are radical cystectomy and intrapelvic lymph node dissection, but 50% of patients experience recurrence within 2 years after surgery. The recurrence after surgery is associate with T3 stage, the presence of invading soft tissue around the bladder and N1, lymph node metastasis. Therefore, various methods are being tried to reduce recurrence and metastasis, among which preoperative chemotherapy has been reported to increase survival rate. Based on this, preoperative chemotherapy followed by radical cystectomy are also recommended. However, there are several limitations; The surgery may be delayed in case of non-responsive to chemotherapy, the difficulty of tolerance of chemotherapy as the patients are relatively old in bladder cancer. Therefore, the preoperative concurrent chemoradiotherapy can be considered as a treatment effectively lower the recurrence. In several retrospective study has reported that preoperative radiation induces the down-staging and leads to prolonged progression free survival. However, after radical cystectomy, there is discomfort for patients regarding the removal of the bladder. Treating the bladder while preserving the bladder is getting its attention. The representative treatment is performing neoadjuvant concurrent chemotherapy followed by transurethral resection of bladder tumor. The bladder preserving treatment is performed in patients who have unresectable, locally advanced bladder cancer or are not medically appropriate for surgery. The 5-year overall survival is reported to be around 50-60%. To date, no clinical trial has been conducted to compare whether concurrent chemoradiotherapy can achieve the comparable clinical outcome as radical cystectomy in operable conditions. Therefore, in order to perform the bladder preserving treatment, a platform selecting patients who can preserve the bladder from bladder preserving treatment in advance is needed. Responsiveness to radiotherapy is a combination of various factors, and radiation sensitivity of tumors is the most important. The recent study has been demonstrated that physician can predict radiation sensitivity using genomic data. In this study, we intend to develop a platform that can predict responsiveness to radiotherapy and select patients who can preserve bladder using genomic information.

This is a multi-center study and the aim is to develop and validate an Artificial Intelligence (AI) -based histologic analysis tool to predict responsiveness to intravesical Bacillus Calmette-Guérin (BCG) and intravesical chemotherapy in intermediate and high-risk non-muscle invasive bladder cancer patients.

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Introduction Bladder cancer is the most common malignancy involving the urinary system and the ninth most common malignancy worldwide. Urothelial carcinoma is accounts for approximately 90 percent of bladder cancers in the western world. In the United States, approximately 80,000 new cases and 17,000 deaths occur each year due to bladder cancer. Approximately 75% of patients present with superficial disease (Ta and T1), while 25% present with muscle invasive (T2 or greater) disease. Overall, 70% of treated tumors recur, with 30% of recurrent tumors progressing to muscle invasive disease. The majority of these patients have a recurrence after endoscopic resection, thus lifelong surveillance with periodically cystoscopy is recommended. Cystoscopy, which is the "gold standard" for the detection of bladder cancer, is an expensive and invasive procedure, and it also can miss a flat lesion, especially carcinoma in situ which is considered a high grade malignant condition, therefore better follow-up tools should be developed in order to address those issues. Voided urinary cytology is a useful noninvasive adjunct to cystoscopy due to its high specificity, more than 90%. Although it has a high sensitivity at detecting high-grade lesions, between 80 to 90%,, in low-grade its sensitivity is very low, between 20 to 50%. Amongst the non-muscle-invasive, low grade tumors will progress to muscle-invasive or metastatic cancer at approximately 10% and roughly a third of high-grade tumors progress, therefore, close monitoring and early detection of all lesions are important for management, and noninvasive tumor markers with high accuracy for the detection of all grades of urothelial carcinoma will significantly reduce patient cost, anxiety and morbidity. Cystoscopy in combination with cytology remains the most effective means of detecting bladder cancer. However, cystoscopy is an invasive procedure, and while cytology remains a useful method for detecting high grade tumors, its utility in detecting low grade tumors remains limited due to the lack of distinguishing cytological features between low grade disease and reactive processes. Currently there are several markers available or under investigation for the detection and monitoring/surveillance of bladder cancer, most of them have higher sensitivities, especially when used to identify low grade disease, but with lower specificities when compared to cytology. Furthermore, all of these tests must still be utilized in conjunction with cystoscopy findings. Recently, cell-free DNA (cfDNA) isolated from urine supernatant has been shown to have great potential in bladder cancer detection and surveillance. Bladder cancer exhibits unique genetic features that can be identified from sequencing and expression of cfDNA. Aim of study: The aim of this study is to establish a method for a personalized urinary biomarker with the usage of well explored urothelail cancer genetic mutations in urine cfDNA, for the detection of bladder cancer presence.

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors.

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.

This phase I trial studies the side effects and best dose of pembrolizumab when given together with docetaxel or gemcitabine hydrochloride in treating patients with previously treated urothelial cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or that has spread from the primary site (place where it started) to other places in the body (metastatic). Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with docetaxel or gemcitabine hydrochloride may be a better treatment for urothelial cancer.

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy