View clinical trials related to Urinary Bladder Neoplasms.
Filter by:The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
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.
The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.
Synopsis Rationale Patients with T1 urinary bladder cancer (UBC) are at high risk for recurrence and progression. However, the prognosis is dependent on several concomitant factors. First and foremost, an accurate diagnosis is imperative for an appropriate disease management. Due to conventional transurethral resection technique, resulting in fragmentation and cauterization of the tissue, the pathological review is often difficult and may result in under or over-staging. A central pathology review of EORTC trial data found only a 43% concordance for T1 tumours compared with staging by a local pathologist. Moreover, risk factors such as concomitant carcinoma in situ (CIS), variant histology (VH) and lymphovascular invasion (LVI) have been associated with even poorer prognosis in patients with T1 UBC. However, there is consistent heterogeneity in reporting these features across studies. There is an unmet need for a clean prospective dataset on T1 UBC to allow an accurate risk stratification in order to aid clinical decision making. Study endpoints The primary objective of the study is to prospectively collect data on patients with primary diagnosis of T1 NMIBC in order - to investigate the therapy failure rates in patients with primary diagnosis of T1 bladder cancer - to investigate the association of clinico-pathologic features such as LVI, VH and CIS, tumor size and number of tumors with pathologic outcomes. - to analyze the accuracy of the local pathologist assessment on the evaluation of pathology features such as tumor stage and grade, substaging according to the microscopic and extensive invasion, LVI, VH and CIS. - to investigate the inter-observer variability among different local pathologist comparing these observations with a central pathology revision performed by expert genitourinary pathologist. - to develop a clinically applicable risk stratification tool which may guide physicians during patient counselling and decision-making regrading adjuvant therapies or early cystectomy Methods Patients with primary diagnosis of UBC and scheduled for transurethral resection of bladder at international urology departments will be prospectively recruited. Patients with confirmed diagnosis of T1 UBC will be included in the study All selected patients will be asked to sign a written informed consent and any locally required privacy act document authorization prior to TURB. Furthermore, all patients will be required to provide consent for central pathology revision. Patients will receive adjuvant treatments (i.e. intravesical therapy or early cystectomy) according to guidelines and clinical standards. All data regarding these treatments will be prospectively collected during the study period or patient death. The clinical data of patients included in the study will be prospectively collected at each center and saved within an electronic case report form (eCRF) using the Castor platform (Castor www.castoredc.com). After combining the data sets from the different centers, reports will be generated for each variable identifying missing or inconsistent data. Incongruities will be solved before freezing the final database. Protected health information (PHI) will be unavailable to investigators at other sites. Follow-up chart abstractions will occur at 6-month intervals until the patient is deceased, lost to follow-up, or the study is terminated. Pathologic specimens will be scanned and uploaded to the eCRF to allow a central pathologic revision. Rationale for patient number Recurrence rates for T1 bladder cancer are estimated to be up to 50% [4]. We plan to include 700 patients in the study. This would allow to detect a 50% failure rate with 4% on either side of the 95% Confidence Interval (proportion 0,50 with 95%CI 0.46-0.54). Future prospects, dissemination and impact A manuscript will be written and submitted for publication on a scientific journal. Any formal presentation or publication of data collected from this trial will be considered as a joint publication by the investigators. Studies originating from this registry could potentially change the risk stratification and, therefore, the management of patients with T1 UBC.
The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.
This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved as standard of care treatment for adult patients with metastatic breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Trastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
The purpose of this study is to assess the performance of multiparametric MRI in detection of occult muscle invasion in urinary bladder cancer
A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.
This prospective randomized controlled trial (RCT) is designed to provide high level evidence describing the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy (NAC) plus RC on survival outcomes of patients with a diagnostic transurethral resection of bladder tumor (TURBt) of non-metastatic muscle invasive bladder cancer (MIBC) (T2-T4 N0 M0) and non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0). Our hypothesis is that performing NAC in the absence of residual disease, after a maximal TURBt, has no survival benefit over performing an early cystectomy. Since no downstaging could be achieved in patients with no residual tumor into the bladder, the benefits of neoadjuvant chemotherapy in this setting could be not significant and it might turn into unnecessary toxicity and a substantial delay to surgical treatment.
In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods. Through assessing the consistency between the testing results and the patients' neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity testing and its application value in the individualized precision medicine for muscle-invasive bladder carcinoma.