Smurf2 Gene Expression in Urinary Tract Tumors

NCT05134623 | Unknown

• 1 other identifier: 0029-20-ZIV
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Neoplasm

Keywords

bllader neoplasm,; SMURF2; biomarker; urinary sediment; immunohistochemistry; PCR

Outcome Measures

Primary Outcomes (1)

• Smurf2 and bladder cancer

  The presence of SMURF2 in bladder tumor tissue compared to normal surrounding tissue

  6 months

Secondary Outcomes (2)

• Smurf2 and bladder cancer

  6 months

• Smurf2 and bladder cancer

  6 months

Interventions

immunohistochemistry of tumors samples DIAGNOSTIC_TEST

routine resection of tumors, further analysis and immunohisochemical staining of the tissue slides.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients, diagnosed with bladder tumors, referred for transurethral resection

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziv Hospital: lead
• Azrieli Faculty of medicine, Bar Ilan University, Safed, IL: collaborator

Related Publications (1)

• Manikoth Ayyathan D, Koganti P, Marcu-Malina V, Litmanovitch T, Trakhtenbrot L, Emanuelli A, Apel-Sarid L, Blank M. SMURF2 prevents detrimental changes to chromatin, protecting human dermal fibroblasts from chromosomal instability and tumorigenesis. Oncogene. 2020 Apr;39(16):3396-3410. doi: 10.1038/s41388-020-1226-3. Epub 2020 Feb 26.

  PMID: 32103168 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

parafin sections of bladder tumors obtained during trans urethral resection

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ran Katz, MD

  Ziv Medical Center

  STUDY DIRECTOR

Central Study Contacts

Ran Katz, MD

CONTACT

+972-4-6828775; rank@ziv.gov.il

Hiba Khuri, MSc

CONTACT

+972-52-5100979; hibak@ziv.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: November 26, 2021
• Study Start: December 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share