View clinical trials related to Urinary Bladder Neoplasms.
Filter by: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.
Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.
Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy
The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.
The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
Study design This study is a Phase III, randomized, open-label, multi-center, global study to determine the efficacy of a single immediate intravesical chemotherapy instillation (SI) in the prophylaxis of intravesical recurrence after diagnostic uretero-renoscopy (URS) of patients 18 years of age or older with the fist diagnosis of UTUC. This study will randomize 394 patients globally Patients will be randomized in a 1:1 ratio to the interventional arm or to observation. Study period This study will include a screening period, a treatment and disease assessment period, safety follow-up visits and a 5-year survival follow-up period to begin immediately after the treatment. Screening period: The period up to 28 days prior to intervention during which the screening procedures occur. Treatment and disease assessment period: The period starting the day of diagnostic URS (Day 0) during which patients receive their assigned treatment (Day 0 to day 1) and disease assessments are performed. All patients must follow the disease assessment schedule, which includes disease assessments at screening and every 3 months (±1 week) from the date of intervention until 24 months from the date of randomization, and then every 6 months for up to 5 years. The treatment and disease assessment period will end at the time of intravesical recurrence, death, or MINERVA-CTU decision to terminate the trial early. Safety follow-up visits: Every patient in this study will be assessed for the occurrence of adverse events (AEs) and serious adverse events from the time of signed informed consent until 90 days after the administration of SI. All patients who receive SI will have safety visits 4, 8, and 12 weeks following administration of SI. Safety assessments include targeted physical examination, complications according to Dindo-Clavien classification and patient-reported outcomes (PRO) assessments. Survival follow-up period: Patients will be followed up at in-clinic site visits, by telephone contact, or by contact with the patient's current physician for up to 5 years from the date of randomized into this study. Objectives Primary objective Efficacy of a SI in the prophylaxis of intravesical recurrence after diagnostic URS for UTUC Secondary objectives - Time to intravesical recurrence - 5-years intravesical recurrence rates - Incidence of high-grade BCa recurrence - Incidence and gravity of adverse events (AEs) due to the SI - To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit (optional) - To collect and store DNA according to each country's local and ethical procedures for future exploratory research into somatic mutations and genes/genetic variations that may influence oncologic outcomes, to study treatments and susceptibility to disease (optional) - To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation - To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms Target study population The study population includes patients 18 years of age or older with a primary diagnosis of UTUC, scheduled for diagnostic URS Duration of treatment Patients randomized to the interventional arm will receive a SI within 24h after diagnostic URS. In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS. Follow-up of subjects post discontinuation of study treatment Patients who have discontinued study treatment due to toxicity, symptomatic deterioration, intravesical recurrence or investigator's decision will be followed up for survival until 5 years from the date of diagnostic URS. Survival All randomized patients, regardless of disease status, will be followed up for survival until 5 years from the date of diagnostic URS. Investigational product, dosage, and mode of administration Patients randomized to the interventional arm will receive a SI. The chemotherapy will be at investigator's discretion and institutional availability. The selected chemotherapy must be approved by the MINERVA-CTU in discussion with the local investigator. Statistical methods This study will randomize 394 patients globally. Patients will be randomized 1:1 to SI or observation. Randomization will be stratified by the following factors: 1. Center 2. EAU UTUC risk stratification
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.