Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
Bladder TumorThis is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.
Onco4D(TM) Biodynamic Chemotherapy Selection for Bladder Cancer Patients
Bladder CancerMillions of cancer patients every year receive chemotherapy with only a 20-60% probability of pathological response, while most experience adverse side effects that lower quality of life without prolonging it. Reliable identification of ineffective therapies can eliminate needless human suffering while increasing overall probability of positive response to treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits strong resistance to a therapy prior to its final selection by the oncologist. However, there are no effective methods for quickly assessing patient chemotherapy resistance. Patient Derived Xenograft (PDX) models have replaced older Chemotherapy Sensitivity and Resistance Assays (CSRAs) to some degree, but both technologies suffer from long testing times, high cost, and/or low accuracy. Motility Contrast Tomography (MCT) has recently emerged as a technology that measures the biodynamic response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue. Several small scale animal, xenograft, and human studies have shown this phenotypic profiling technique to be highly accurate in prediction of response and resistance to chemotherapy. This project will be the first human trial of biodynamic phenotyping to predict chemotherapy response among bladder cancer patients. Specifically, the study cohort will include patients selected for neoadjuvant chemotherapy treatment, because this setting offers the opportunity for near-term outcome measurement at the time of post-chemo surgery. Pre-therapy fresh tumor specimens will be imaged using MCT, and the resulting bio-dynamic signatures will be compared to confirmed pathological response at the time of surgery. Observation of a high predictive value will provide the basis for expanded clinical trials and prompt commercialization of a biodynamic chemotherapy selection assay for bladder and other cancer patients.
Basal Like Bladder Cancer : Signature and Therapeutic
Muscle Invasive Bladder CancerMolecular TaxonomyMuscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.
The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study
Cardiovascular DiseasesChronic Obstructive Pulmonary Diseases3 moreThe main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking. The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit. Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.
The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT
Bladder CancerInvestigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results. To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.
Open Versus Laparoscopic Radical Cystectomy
Bladder CancerTo date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.
A Retrospective Analysis of Spinal Anaesthesia for TURBT Procedures in Elderly Patients
Spinal AnaesthesiaBladder Tumor1 moreThe aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.
Evaluation of the PhageTech Virus BioResistor
Bladder CancerTo evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.
Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer...
Bladder CancerRATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future. PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.
Changes in Prostate Specific Antigen Levels During Synergo Therapy-Intravesical Chemotherapy Instillations...
Bladder CancerPURPOSE: We determined whether Synergo therapy- intravesical chemotherapy instillation combined with hyperthermia instillation is associated with elevated prostate specific antigen (PSA). MATERIALS AND METHODS: We will treat 25 consecutive patients with bladder cancer with a 6-week course of Synergo therapy, followed by cystoscopy at 6 weeks. Blood samples for PSA determination will obtain before each synergo therapy application and at cystoscopy with each patient also serving as a control. Evaluating changes in PSA level in patients undergoing treatment with Synergo delivered local hyperthermia combined with intravesical instillation of Mitomycin C for adjuvant treatment or pt. with recurrent tu of bladder post TURT with BCGtreatment.