Active clinical trials for "Urinary Bladder Neoplasms"

The purposes of this study is to evaluate a new genetic-based test which will identify patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have specific genes, which will increase their chances of recurrence of cancer after their surgery. Some patients who are diagnosed with bladder cancer and have their had bladder removed, will have a recurrence of cancer sometime after their surgery. This recurrence is usually caused by tumor cells that originated from the bladder tumor and traveled to other parts of the body, which is called metastatic cancer. Some patients are more likely than others to have metastatic disease. This test may help in identifying these patients who might develop metastases from having these specific genes.

This research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a microscope to see how they respond. This may allow doctors to predict how likely the cancer cells are to spread in the body. The biomarker test uses laboratory testing of samples from patients to study genes and other molecules that may predict the cancer invasiveness. Comparing two different ways of predicting cancer aggressiveness may help doctors identify how well they work, and may eventually allow doctors to predict aggressiveness without needing to take a biopsy.

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.

Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. The investigators postulate that Xpert® test might be used to demonstrate the presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.Urines of BCG treated patients are rich in immune system elements (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with urinary biomarkers. This study will allow assessing the effect of the complex inflammatory milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer assay.

This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.

The purpose of this study is to explore the feasibility and efficacy of a 12-week, home-based exercise program in bladder cancer patients undergoing curative intent neoadjuvant chemotherapy and RC.

A. Synopsis This protocol comes to direct the experiment to be performed on the Aqueduct Automatic Continuous Irrigation system. The Aquaduct System is aimed at reducing risks to the patient by decreasing the irrigation fluid pressure he may be exposed to, reducing the procedure time and therefore the anesthesia time, reducing the manual handling of the sterile bags and the risk of contamination and more. In general since there is no new procedure suggested and the equipment does not actually come into contact with the human body in any direct way, there is no need to have a clinical study for the regulation purpose. The reason for performing this experiment is to demonstrate the new system and to find out the best way to operate it in order to improve the process and reduce risks. This information will serve the development of most suitable automation solution for achieving the long desired continuous irrigation. The experiment will be performed in the OR in MIS procedures, and will replace the standard gravitational manual method of performing the irrigation. The surgeons and the medical staff of the OR will be directed with the set up and operation of the system prior to using it. The experiment will be accompanied at all times with a knowledgeable representative of the research originator. A maximum of 30 procedures will be analyzed during a period of approximately one month. The surgeons and the medical staff will report their impression of using the system during the procedures and will recommend the best settings achieved. This information will be used to improve the system performance and design.

Bladder cancer (BC) is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in Danish men with an incidence of more than 2000 and a prevalence of 650 per 100000 citizens. BC have a poor prognosis even when treated radically with cystectomy. The 5-year survival rate after radical cystectomy for T2 muscle-invasive tumors are 23-60 % and decreasing further to 23 % for T4 muscle-invasive tumors. BC is highly recurrent with an overall recurrence of 50 %. BC is considered to be the number one cost-expensive malignant disease of all malignant diseases measured by lifetime per patient in the United States. The degree of muscle invasion in the bladder is histologically and clinically defined by a transurethral resection of the bladder tumor (TUR-B). The tumor is resected radically if possible. Thus, it is of absolute importance that a sufficient TURB is performed, since a resection to the muscle layer of the bladder wall, the detrusor, is of prognostic value for the patient. Problem: The quality of the surgery is depending on the surgeon A recent international meta-analysis shows that up to 78% of the tumors are not radically resected. When these tumors are resected in a second TURB 24-28% of the tumors are found to be muscle-invasive. Furter, there is evidence indicating that the outcome of the resection is dependent on surgeon experience. Large multi-centre retrospective studies have showed that resident-involvement in TURB results in less radical bladder tumor resections and result in higher recurrence rates of bladder tumors and high numbers of re-admission after TURB. In Denmark, the current surgical curriculum states that TURB is a learning goal in the first year of the training. The formal training in TURB in Denmark is traditional apprenticeship in accordance with the Halstedian principle "see one, do one, teach one". No validated simulator-based certification in TURB exits today in Denmark or internationally. Purpose: Start from the beginning - improve the training of the surgeons Simulator-based training in surgical procedures is an effective method to gain surgical skills in a large spectrum of surgical procedures. In the initial phase of the learning curve it has even proven more effective than traditional apprenticeship and thus both the World Health Organization (WHO) and the European Association of Urology (EAU) calls for implementation of simulation training programmes in medical surgical education. The aim of this project is to validate and develop a simulator-based urological training programme in TURB, to implement the programme nationally and internationally, and hereby improve the outcomes in the surgical treatment of patients with bladder cancer.

The standard non-surgical treatment for muscle invasive bladder cancer is concurrent chemo-radiotherapy. This treatment is associated with long term side effects in around a third of patients with up to 12% suffering from grade 3-4 toxicity. Effective radiotherapy depends on delivering a curative dose to the target whilst minimising dose to surrounding tissues to reduce toxicities. As an organ that constantly varies in shape and position, achieving this in bladder irradiation is challenging. Cone beam Computed Tomography (CBCT) has allowed visualisation of soft tissue on treatment and hence image-guided treatment and improved accuracy, but the image quality of CBCT is suboptimal for distinguishing soft tissue boundaries. On the other hand, MRI scans produce superior soft tissue definition and visualisation of tumour bed. This would in turn allow for various ways of optimising treatment and potentially improving outcome. There have been a number of studies evaluating pelvic organ motion in bladder cancer as well as assessing different adaptive radiotherapy strategies. These have included individualized margins, plan of the day and adaptive techniques. Most of these studies have been carried out using CBCT imaging which is often poor quality with limited soft tissue contrast. MRI offers better visualization of the tumour bed and organs at risk (OARs). As a result, the utilisation of MRI in radiotherapy could allow for increased radiation dose to the tumour bed while maintaining minimal dose to surrounding soft tissue. This study will explore the role of MRI imaging in adaptive radiotherapy for bladder cancer with development of a number of theoretical treatment strategies.