Active clinical trials for "Urinary Bladder Neoplasms"

Around 7200 cases of Muscle Invasive Bladder Cancer are diagnosed annually in the Nordic countries combined. Muscle Invasive Bladder Cancer is an aggressive disease and it is linked with high mortality rates. The golden standard of treatment is radical cystectomy (RC) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. In addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. Chemotherapy can be administered before or after surgery, in a neoadjuvant (NAC) or adjuvant setting (AC). Although most patients recover well from surgery, there are significant risks regarding radical cystectomy. The greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. Neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy. The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries: Sweden, Denmark, Iceland and Norway. The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC. The study is divided into three sub-studies. The second sub-study is on the preoperative neutrophil-lymphocyte ratio (NLR). Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC. In addition, NLR has been suggested to correlate with NAC response and outcome after NAC and RC. The used cut-off value for NLR has varied between 2.26-3.0. Patients will be allocated into two groups: low NLR ratio (NLR<3), and high NLR ratio (NLR≥3). The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy. The primary end-point is bladder-cancer specific survival and, and secondary endpoints include progression-free, and overall survival.

Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands

Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

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 AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.

The investigators aim to experiment and implement various deep learning architectures to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, the investigators are interested in detecting bladder tumors from CT urography scans and cystoscopies of the bladder in this project.

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

This proposal will aim to improve the understanding about the treatment decision in the type of urinary diversion and identify patient knowledge gaps about uncertainty around patient decision-making.

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.