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Smurf2 Gene Expression in Urinary Tract Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05134623
Recruitment Status : Not yet recruiting
First Posted : November 26, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
Azrieli Faculty of medicine, Bar Ilan University, Safed, IL
Information provided by (Responsible Party):
Ziv Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Bladder Neoplasm Diagnostic Test: immunohistochemistry of tumors samples

Detailed 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
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Smurf2 Gene Expression in Urinary Tract Tumors - Tissue Immunohistochemitry and Urinary Sediment Analysis
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: immunohistochemistry of tumors samples
    routine resection of tumors, further analysis and immunohisochemical staining of the tissue slides.

Outcome Measures
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Primary Outcome Measures :
  1. Smurf2 and bladder cancer [ Time Frame: 6 months ]
    The presence of SMURF2 in bladder tumor tissue compared to normal surrounding tissue


Secondary Outcome Measures :
  1. Smurf2 and bladder cancer [ Time Frame: 6 months ]
    The distribution of SMURF2 in bladder tumor cells - nucleus to cytoplasm

  2. Smurf2 and bladder cancer [ Time Frame: 6 months ]
    Identification of the SMURF2 product in the urinary sediment using proteomics and PCR


Biospecimen Retention:   Samples Without DNA
parafin sections of bladder tumors obtained during trans urethral resection

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients, diagnosed with bladder tumors, referred for transurethral resection
Criteria

Inclusion Criteria:

  • Identified bladder tumor
  • Scheduled for transurethral resection
  • Informed consent

Exclusion Criteria:

  • Previous bladder, prostate or pelvic irradiation
  • Persistent urinary tract infection
  • Intravesical therpy with BCG within 6 months prior to surgery.
  • Intravesical chemotherapy within 6 months prior to surgery
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05134623


Contacts
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Contact: Ran Katz, MD +972-4-6828775 rank@ziv.gov.il
Contact: Hiba Khuri, MSc +972-52-5100979 hibak@ziv.gov.il

Sponsors and Collaborators
Ziv Hospital
Azrieli Faculty of medicine, Bar Ilan University, Safed, IL
Investigators
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Study Director: Ran Katz, MD Ziv Medical Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT05134623    
Other Study ID Numbers: 0029-20-ZIV
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziv Hospital:
bllader neoplasm,
SMURF2
biomarker
 urinary sediment
immunohistochemistry
PCR
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases