Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05134623 |
| Other study ID # |
0029-20-ZIV |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2021 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
November 2021 |
| Source |
Ziv Hospital |
| Contact |
Ran Katz, MD |
| Phone |
+972-4-6828775 |
| Email |
rank[@]ziv.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
