Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Smurf2 and bladder cancer - research proposal summary - detailed 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 cigarrete 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. 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. In the study, the investigators will collect samples from bladder tumors of patient referred for transurethral resection of a known bladder tumor. The tissue will be processed routinely yet additional slides will be performed and used for immunohistochemical analysis. The investigators will characterize the expression of SMURF2 in the tissue, its abundance, the distribution between the nucleus and cytoplasm and possible differences between the tumors tissue and surrounding normal margins. Further on, the investigators will collect urine samples from patients with these tumors and examine the urinary sediment using PCR and proteomic examination. The data will be used for further research using the SMURF2 product as a possible novel bio-marker for the presence of bladder tumors and for non-invasive detection and follow-up of patients on surveillance following surgical treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05134623
Study type Observational
Source Ziv Hospital
Contact Ran Katz, MD
Phone +972-4-6828775
Email rank@ziv.gov.il
Status Not yet recruiting
Phase
Start date December 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04081246 - Transurethral Modified En Bloc Resection For Large Bladder Tumours. N/A
Completed NCT05540847 - Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block N/A
Terminated NCT00249301 - A Study of MLN8054 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06167356 - Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.
Terminated NCT01200992 - Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer Phase 3
Recruiting NCT04839029 - Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT N/A
Active, not recruiting NCT03138824 - Storz Professional Image Enhancement System Versus White Light Imaging Assisted TURBT for Treatment of NMIBC N/A
Completed NCT03013894 - Confocal Laser Endomicroscopy in the Lower Urinary Tract
Recruiting NCT06416319 - Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct) N/A
Completed NCT00722553 - Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder Phase 2
Active, not recruiting NCT04167631 - Can VI-RADS/ADC Accurately Stage Bladder Cancer?? N/A
Completed NCT03458598 - Pre-Operative Single Shot Rectus Sheath Block N/A
Recruiting NCT04075305 - The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Completed NCT04200963 - A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma Phase 1
Not yet recruiting NCT05467267 - Personalized Urine Biomarker for Patients With Bladder Cancer
Recruiting NCT05022160 - Preventing Catheter Related Bladder Discomfort (CRBD) With Bilateral Pudendal Nerve Block Early Phase 1
Completed NCT03591367 - The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation N/A
Terminated NCT03335059 - Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors. Phase 3
Recruiting NCT05027412 - En Bloc TURBT With Collins Loop vs Conventional TURBT N/A
Recruiting NCT04784507 - En-Bloc Resection of Bladder Tumors Phase 2