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Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population

Primary Purpose

Urothelial Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Expression of Cortactin anti body
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urothelial Carcinoma focused on measuring Cortactin, Urothelial carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with primary urinary bladder carcinoma.

Exclusion Criteria:

  • patients received chemotherapeutic agents.

Sites / Locations

  • Maisa Hashem Mohammed

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with invasive and non invasive urothelial carcinoma

Arm Description

patients with urothelial carcinoma will be subjected to radical cystectomy or trans uretheral resection of the tumor, specimens will be sent to the pathology lab. to be examined.

Outcomes

Primary Outcome Measures

Assessment and correlating Cortactin expression in invasive and non-invasive urothelial carcinoma.
immunohistochemical staining of tumor sections and correlating the immuno-expresion of Cortactin to different tumor parameters as tumor grade, stage and status of lymph nodes involved, inorder to detect the prognostic role of Cortactin in urothelial carcinoma.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2021
Last Updated
July 13, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05070039
Brief Title
Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population
Official Title
Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Urothelial carcinoma is the ninth most common malignant neoplasm worldwide. nearly in all human tumors, actin filaments are involved in lamellopodia or cellular extensions. Cortactin is involved in fixing the actin assembly to enhance cellular penetration. Assessment of Cortactin expression in invasive and non-invasive urothelial carcinoma and recording any significant different expressions may have benefits in developing more effective anticancer chemotherapeutic agents.
Detailed Description
Bladder carcinoma is the 9th most prevalent cancer worldwide. Mostcases are diagnosed in men. Bladder carcinoma is categorized into three disticly different categories; non- muscle invasive, muscle invasive and metastatic bladder carcinoma. Vast majority of all bladder carcinomas are diagnosed as urothelial carcinoma (UC). Squamous cell carcinoma (SCC), adenocarcinoma and other rare types represent the remaining 10%. In Egypt, bladder carcinoma is ranked as the most prevalent cancer . The most important etiological causes for such disease in Egypt are festation by S. haematopium and Cigarette smoking. Cortactin is a 63-65 kDa protein, encoded by a gene located on 11q13. Cortactin activates and binds to Arp2/3 and stabilizes the branched Actin networks. Invadopodia are Actin-rich cellular protrusions, associated with enhanced proteolytic activities in the invasive regions of carcinomas. it is also incorporated in invadopodia, Cortactin expression is enhanced once or rapidly following secretions of transmembrane metalloproteinase, MT1-MMP. Extracellular matrix (ECM) proteolytic cleavage develops soon after secretion of MT1-MMP and Cortactin. increased secretion of Cortactin was studied in a lot of malignant tumors, including melanoma, mammary, pancreatic duct, hepatocellular and colorectal adenocarcinomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
Cortactin, Urothelial carcinoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
formalin fixed and paraffin embedded blocks of urinary bladder malignant neoplasms will be obtained and sectioned. from each block, one tissue section will be stained by H&E, other section will be stained immunohistochemically by anti Cortactin antibodies.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with invasive and non invasive urothelial carcinoma
Arm Type
Other
Arm Description
patients with urothelial carcinoma will be subjected to radical cystectomy or trans uretheral resection of the tumor, specimens will be sent to the pathology lab. to be examined.
Intervention Type
Genetic
Intervention Name(s)
Expression of Cortactin anti body
Intervention Description
assessment of Cortactin immunohistochemical expression in invasive and non-invasive urothelial carcinoma.
Primary Outcome Measure Information:
Title
Assessment and correlating Cortactin expression in invasive and non-invasive urothelial carcinoma.
Description
immunohistochemical staining of tumor sections and correlating the immuno-expresion of Cortactin to different tumor parameters as tumor grade, stage and status of lymph nodes involved, inorder to detect the prognostic role of Cortactin in urothelial carcinoma.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with primary urinary bladder carcinoma. Exclusion Criteria: patients received chemotherapeutic agents.
Facility Information:
Facility Name
Maisa Hashem Mohammed
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population

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