View clinical trials related to Urinary Bladder Neoplasms.
Filter by:This is a phase II randomized study of standard of care (SOC) neo-adjuvant cisplatin chemotherapy (NAC) versus NAC plus durvalumab in patients with either clinical or pathologic intra-pelvic node-positive urothelial carcinoma of the bladder. Patients with cTanyN1-3M0 via American Joint Committee on Cancer (AJCC) 8th edition staging30 will be considered tor enrollment in this trial. We plan to enroll 60 patients. Patients will be randomized 2:1 to the intervention arm with durvalumab plus NAC vs SOC NAC. In patients randomized to receive, durvalumab will be continued as maintenance every 4 weeks until either relapse or 1 year, whichever event occurs first. Tissue collection will occur as a biopsy prior to initiation of neo-adjuvant therapy via both transurethral biopsy of bladder and lymph node biopsy. Tissue will again be collected at the time of radical cystectomy or, in patients who are no longer surgical candidates, in the form of biopsy as standard of care. Blood and urine will be collected at baseline, week 2, week 6, week 16, and at the 6 week-post surgery visit for analysis of correlative studies.
This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate some of the challenges in the patient experience (logistical, expense, and comfort) when receiving treatment for low-grade non-muscle-invasive bladder cancer at intermediate risk of recurrence (LG IR NMIBC).
In this study, investigators aim to reveal the harmful effects of increasing consumption of homemade beer in recent years on the urinary tract. The high amount of carbonyl compounds in the content of homemade beer has been proven by studies. In this study, which will be conducted in the form of a questionnaire, it is aimed to evaluate the effects of the consumption of homemade beer and the long-term exposure of the urinary system to carbonyl compounds.
Smurf2 and bladder cancer - research proposal summary The Smurf2 gene was recently identified as a tumor suppressor gene. It is an E3 ubiquitin ligase and carries a significant role in major cellular processes such as cell division, genomic stability, DNA repair as well as resistance to anti-tumoral drugs. Recent studies showed that in several common tumors (prostate, breast, osteosarcoma etc.), a significant decrease in the expression or activity of Smurf2 can be noted, making the cells more susceptible to malignant transformation and the tumors more aggressive and highly resistant to various medications. Bladder cancer is no. 4 cancer in men and 6 in women, and a major cause of cancer related death. Common risk factors are smoking and occupational exposure to aniline dyes or aromatic amines. Its' most common presentation is painless hematuria. Once the diagnosis of a bladder tumor is made, endoscopic resection of the tumors is performed. Superficial tumors of low malignancy may be treated by repeated resections, highly malignant tumors require additional therapy and aggressive tumors invading the bladder muscle layer require radical surgery and chemo-radiotherapy. Therefore, all patients are closely monitored by repeated cystoscopies (endoscopic inspection of the bladder), each 3 months, lifelong. In an effort to minimize patients' discomfort, there is a constant search for a reliable biomarker in the urine of patients. A marker with good sensitivity and specificity will predict in a noninvasive fashion early recurrence or absence of bladder tumors, sparing the need for invasive cystoscopy. The presence of a biomarker may be used as prognostic factor or a measure of response to therapy. The aim of this research is to characterize the presence of smurf2 in bladder tumors and determine whether it may be utilized as a reliable biomarker for bladder cancer.
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.
The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the tumor.
There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.
To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.
This is a first in human, multicenter, open label, Phase 1a and 1b dose-escalation and dose-expansion study to establish the maximum tolerated dose, recommended Phase 2 dose, and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose escalating fashion in subjects with advanced solid tumors. Up to 40 subjects will be enrolled into the Phase 1a dose-escalation part of the study. The study will be conducted in the United States at approximately 7 to 10 sites. Every effort will be made to ensure approximately 50% of all subjects enrolled into Phase 1a of this study are subjects with the tumors of special interest including squamous cell carcinoma of the head and neck, colorectal cancer, non-small cell lung cancer, and transitional cell carcinoma of the bladder. Subjects with other solid tumor types are also eligible provided study selection criteria are met and they do not exceed 50% of all enrolled subjects. All subjects in Phase 1b will enroll with clear cell renal cell carcinoma. The Phase 1a study will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to 20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the fasting state with water at least 1 hour before food or at least 2 hours after food. The Phase 1b dose-expansion will be at a single dose level of 75 mg based on the safety, tolerability, PK/PD results from Phase 1a to obtain additional safety and preliminary efficacy information. At the discretion of the safety monitoring committee and sponsor, the cohort may be expanded to enroll additional patients and/ or 1-2 additional cohorts will be opened. Up to 30 subjects may be enrolled in the Phase 1b portion of the study at the 75 mg dose. Replacement patients will be enrolled if necessary. Subjects will be dosed until unacceptable toxicity, disease progression per immune-related Response Evaluation Criteria in Solid Tumors, discontinuation of treatment for other protocol allowed reason (eg, subject refusal), any other administrative reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes, dosing in Phase 1a and 1b will occur in 3 week cycles and computed tomography scans will be conducted once every 6 weeks from Cycle 1/Day 1, with the first postbaseline scan after 6 weeks of dosing (precycle 3) until confirmed disease progression, death, start of new anticancer therapy, withdrawal of consent, or end of study, whichever occurs first.
We will conduct a Phase I trial testing whether local cystoscopic injection of tremelimumab into the bladder wall in combination with systemic administration of durvalumab in localized bladder cancer will stimulate an effective anti-tumour immune response with minimal systemic immune response and clinical toxicity.