View clinical trials related to Urinary Bladder Neoplasms.
Filter by:Introduction Bladder cancer is the most common malignancy involving the urinary system and the ninth most common malignancy worldwide. Urothelial carcinoma is accounts for approximately 90 percent of bladder cancers in the western world. In the United States, approximately 80,000 new cases and 17,000 deaths occur each year due to bladder cancer. Approximately 75% of patients present with superficial disease (Ta and T1), while 25% present with muscle invasive (T2 or greater) disease. Overall, 70% of treated tumors recur, with 30% of recurrent tumors progressing to muscle invasive disease. The majority of these patients have a recurrence after endoscopic resection, thus lifelong surveillance with periodically cystoscopy is recommended. Cystoscopy, which is the "gold standard" for the detection of bladder cancer, is an expensive and invasive procedure, and it also can miss a flat lesion, especially carcinoma in situ which is considered a high grade malignant condition, therefore better follow-up tools should be developed in order to address those issues. Voided urinary cytology is a useful noninvasive adjunct to cystoscopy due to its high specificity, more than 90%. Although it has a high sensitivity at detecting high-grade lesions, between 80 to 90%,, in low-grade its sensitivity is very low, between 20 to 50%. Amongst the non-muscle-invasive, low grade tumors will progress to muscle-invasive or metastatic cancer at approximately 10% and roughly a third of high-grade tumors progress, therefore, close monitoring and early detection of all lesions are important for management, and noninvasive tumor markers with high accuracy for the detection of all grades of urothelial carcinoma will significantly reduce patient cost, anxiety and morbidity. Cystoscopy in combination with cytology remains the most effective means of detecting bladder cancer. However, cystoscopy is an invasive procedure, and while cytology remains a useful method for detecting high grade tumors, its utility in detecting low grade tumors remains limited due to the lack of distinguishing cytological features between low grade disease and reactive processes. Currently there are several markers available or under investigation for the detection and monitoring/surveillance of bladder cancer, most of them have higher sensitivities, especially when used to identify low grade disease, but with lower specificities when compared to cytology. Furthermore, all of these tests must still be utilized in conjunction with cystoscopy findings. Recently, cell-free DNA (cfDNA) isolated from urine supernatant has been shown to have great potential in bladder cancer detection and surveillance. Bladder cancer exhibits unique genetic features that can be identified from sequencing and expression of cfDNA. Aim of study: The aim of this study is to establish a method for a personalized urinary biomarker with the usage of well explored urothelail cancer genetic mutations in urine cfDNA, for the detection of bladder cancer presence.
Urinary bladder tumors with a frequency of 13000 new cases a year, have a heterogeneity in terms of survival according to the stage of local flooding. This is an aggressive tumor because of the potential muscular infiltration. It seems important in this case (muscular invasion), to increase the global survival. The anatomopathological analysis of the TURB (biopsy byTrans-Urethral Resection of the Bladder) is actually the gold standard for the pathology of bladder tumor. No need an imaging to discuss about the small and non muscular invasive tumor. But in most cases, the use is to perform at last an ultrasound or a CT-Scan, specially for the invasive tumor. A lot of studies show that CT SCAN. is not the best way of investigation for the bladder muscle invasion. However, as in the prostate cancer with the PIRADS Score, the MRI can be useful for the bladder, thanks to the sequence improvement to the machine. The study from Panebianco 2018, starts to talk about the MRI in the urinary bladder cancer with new radiological terms. It creates a new score called VIRADS score (as the PIRADS score already used for the prostate cancer). But it is never compared with the results of the TURB. Our study compares the results of the MRI pre operative versus the pathology results on prospective analysis. Main objective : T tumoral score in urinary bladder tumor : MRI versus pathology results. Secondary objectives : the contribution of diffusion weighted MRI in the bladder neoplasm. Type of study : interventional study, prospective, mono centric, single arm, intent-to-treat
Nowadays, Immune Checkpoint Inhibitor (ICI) has become one of the new drugs for the treatment of advanced uroepithelial carcinoma. The Food and Drug Administration (FDA) approved ICI for bladder cancer (BC) patients who cannot tolerate cisplatin chemotherapy and whose tumors express programmed cell death protein ligand-1 (PD-L1). However, the efficacy of ICI in bladder preservation therapy for muscular invasive bladder cancer (MIBC) is unknown. With the progressive clinical confirmation of the efficacy of immunotherapy, ICI has moved from second-line to first-line treatment in the indication of advanced unresectable BC. It even has been used in the neoadjuvant and postoperative adjuvant therapy for MIBC and non-muscle invasive bladder cancer (NMIBC) where Bacillus Calmette-Guérin (BCG) therapy has failed. Available studies have shown that neoadjuvant immunotherapy can achieve a pathological complete response (pCR) of 31%-42% for MIBC, regardless of using a single drug or combination, which is higher than that of neoadjuvant chemotherapy, and the incidence of side effects associated with neoadjuvant immunotherapy is lower than that of neoadjuvant chemotherapy, providing an effective treatment option for cisplatin-intolerant patients. Studies have shown that radiotherapy leads to immunogenic cell death, which results in the release and presentation of tumor antigens and directs the recruitment and activation of T cells. It also induces increased expression of PD-L1 in tumor cells, which in turn improves the efficacy of immunotherapy. Thus ICI combined with radiotherapy has a synergistic antitumor effect and does not produce serious toxic side effects similar to those associated with chemotherapeutic agents. This study proposes a novel neoadjuvant immunotherapy-based integrated bladder preservation therapy (neoadjuvant immunotherapy + TURBT + postoperative adjuvant radiotherapy combined with immunotherapy) and investigates the effectiveness and safety of this strategy in bladder preservation treatment strategy.
Bladder carcinoma (BC) is the 13th leading cause of cancer mortality worldwide . In Egypt, BC is the third common malignant tumor. Its incidence is 8.7% of all malignant tumors in both sexes with more predominance in males as reported by National Cancer Registry with more expected cases in the future. There are different histological variants of BC which show different phenotypic, biological and prognostic impacts. The most common histological type of BC is urothelial carcinoma which constitutes about 90% of all bladder cancers. Squamous cell carcinoma, adenocarcinoma and other rare types represent the remaining 10%. Carcinoma of the bladder is considered a heterogeneous stem cell tumor with increasing morbidity and death rates if it is not treated properly. The presence of cancer stem cells (CSCs) is associated with tumor progression, recurrence, metastasis, and resistance to conventional chemotherapy and makes complete elimination of the tumor difficult. Successes in treatment plans need more understanding of the CSCs population and their molecular biology. The most important items of CSCs regulatory core are transcription factors such as OCT4, SOX-2, and Nanog. They play an important role in the regulatory network for maintaining the 'stemness' state of stem cells. SOX2 (short for Sex determing Region Y - box 2), a High Mobility Group (HMG) domain transcription factor is member of the SRY-related HMG-box (SOX) family of transcription factors involved in the pluripotency, self-reappearance and differentiation of embryonic stem cell. Cancer immunotherapy starts with a proper understanding of tumor immuno-biology. Study of the tumor microenvironment revealed the importance of immune checkpoints in facilitating tumor immunological escape, leading to the development of multiple novel therapeutics targeting the PD-1/PD-L1 (programmed cell death protein 1, "CD279" programmed death ligand 1, "CD274") immune checkpoints. And recently the expression levels of PD-L1 are closely associated with CSCs immune escape. PD-1 is a T-cell immune inhibitory checkpoint that inhibit T-cell activation and contributes to the immunosuppressive tumor microenvironment. PD-1 is also expressed on activated B cells and natural killer cells. PD-1 is activated by binding to its ligand; PD-L1, which is a type I trans-membrane glycoprotein. Many cell types express PD-L1, including placenta, vascular endothelium, hepatocytes and mesenchymal stem cells, also B cells, T cells, dendritic cells, macrophages, and mast cells. PD-L1 is considered to be a co-inhibitory factor of the immune response, it can combine with PD-1 to reduce the proliferation of PD-1 positive cells, inhibit their cytokine secretion and induce apoptosis. PD-L1 also plays an important prognostic and predictive value in various malignancies where it can attenuate the host immune response to tumor cells. However, little is known about the role of PD-L1 and its relation to SOX2 in urinary bladder carcinoma including its different histopathological variants. In this study, the main objective is to evaluate the immunohistochemical expression of PD-L1 to CSCs marker (SOX2) in urinary bladder carcinoma as a prognostic factor and search for new prospective targeted cancer therapy.
An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer.It's arm to evaluate the neoadjuvant treatment of Her2-positive Muscle-invasive Bladder Cancer in patients with objective response rate (ORR),Duration of response (DoR) , progression-free survival (PFS), overall survival (OS), and safety.
Men over 40 years of age, and women over 50, smokers or former smokers with a smoking rate greater than 10 packs/year and the presence of microhematuria >25 red blood cells per field in the microscopic analysis are at high risk of bladder cancer, so cystoscopy and uroTAC is advised in the AUA Guidelines. The investigators hypothesize if cystoscopy can be omitted in case of having a negative biomarker test and a normal uro-CT. Main objective: To determine sensitivity, specificity, positive and negative predictive value of "Uromonitor" (molecular DNA based urine marker) in the included population, in relation to the presence of urothelial cancer in the bladder, comparing it with cystoscopy.
To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.
this study is designed to compare intrathecal bolus of bupivacaine-dexmedetomidine versus continuous epidural fentanyl infusion in providing effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery. The hypothesis Intrathecal bolus of bupivacaine-dexmedetomidine could replace continuous epidural fentanyl infusion and would be an enough intraoperative analgesic modality with good intraoperative hemodynamic stability and less postoperative complications in orthotopic urinary bladder diversion patients. Aim of the work The aim of this protocol is to document that intrathecal bolus of bupivacaine-dexmedetomidine analgesia (a low coast analgesic modality) can replace continuous epidural fentanyl infusion analgesic modality with effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery.
This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.
Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression. Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor. This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients. This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.