View clinical trials related to Urinary Bladder Neoplasms.
Filter by:Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant to Bacillus Calmette-Guérin (BCG)-therapy. Patients are initially treated with 12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase). Patients who achieve a complete response (CR) after the 12 weekly instillations entered the maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months.
Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage. Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging. Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival. Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.
Clinically node positive (cN+) bladder cancer carries a poor prognosis, especially in patients who are unable to receive or fail to respond to neoadjuvant chemotherapy. Immune checkpoint inhibitor (ICI) therapy is FDA-approved in advanced bladder cancer for patients unable to receive or failing to respond to platinum-based chemotherapy. The present study seeks to determine if next-generation radiation therapy (personalized ultrafractionated stereotactic ablative radiotherapy, or PULSAR) is feasible and effective in patients receiving ICI for bulky cN+ bladder cancer.
Treatment will consist of a PARP inhibitor (niraparib) monotherapy priming period (cycle 0; 21 days); an anti-PD-1 antibody (Dostarlimab ; TSR-042) will then be added from C1D1 every 21 days in combination for the first 4 cycles, and then every 42 days. Disease will be assessed every 2 cycles (6 weeks) from C3D1 by CT-scan (or MRI or bone scan, if relevant). Patients still under treatment after 1 year may have tumor evaluation spaced out every 3 cycles
Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.
Purpose To investigate the significance of time to re-staging transurethral resection (re-TUR) on recurrence and progression rates in patient with high-risk non-muscle-invasive bladder cancer. Methods Patients diagnosed with primary high risk non-muscle-invasive bladder cancer were included to the study. The patients were randomly seperated into 3 groups acoording to Re-TUR timing. In group 1,2, and 3, the time interval between initial and re-TUR were 14-28 days, 29-42 days, and 43-56 days respectively. Kaplan -meier plots were used to estimate differences in recurrence free survival (RFS) and progression free survival (PFS) rates. Cox regression analysis was used to assess the effect of time from initial TUR to re-TUR on oncological outcomes. Results A total of 109 patients with high risk non-muscle-invasive bladder cancer were randomly divided into 3 groups. Twenty patients in group 1 (14-28 days), 22 patients in group 2 (29-42 days), and 29 patients in group 3 (43-56 days) completed the study. The mean follow-up was 20 ± 8.9 months. Kaplan-Meier plots showed no differences in RFS and PFS rates between the three groups. Cox regression analysis demonstrated that only tumor number was found to be a prognostic factor on RFS rates. Conclusion Our prospective study demonstrated that time laps from initial TUR to re-TUR did not significantly affect on RFS and PFS rates.
To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.
This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely. Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.
This is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. This is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (LRC).