Urothelial CarcinomaNCT05070039
Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population
A study testing Expression of Cortactin anti body in people with Urothelial Carcinoma, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Expression of Cortactin anti body
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with primary urinary bladder carcinoma.
Who cannot join
- patients received chemotherapeutic agents.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- Expression of Cortactin anti body
- Keywords
- Cortactin, Urothelial carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expression of Cortactin anti bodyGenetic
assessment of Cortactin immunohistochemical expression in invasive and non-invasive urothelial carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| patients with invasive and non invasive urothelial carcinoma | Other | 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. Receives: Genetic: Expression of Cortactin anti body |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jul 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Hashem Mohammed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070039
- Sponsor's protocol ID
- Soh-Med-21-09-44
- Status last verified
- Jul 2022
- First submitted
- 19 Sep 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population
- ClinicalTrials.gov ID
- NCT05070039
- Acronym / sponsor ID
- Soh-Med-21-09-44
- Conditions
- Urothelial Carcinoma
- Keywords
- Cortactin, Urothelial carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients with invasive and non invasive urothelial carcinoma | Other | Genetic: Expression of Cortactin anti bodypatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with primary urinary bladder carcinoma.
Key exclusion criteria (1 listed)
- patients received chemotherapeutic agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expression of Cortactin anti bodyassessment of Cortactin immunohistochemical expression in invasive and non-invasive urothelial carcinoma. | Genetic | patients with invasive and non invasive urothelial carcinoma |
Primary outcome
Assessment and correlating Cortactin expression in invasive and non-invasive urothelial carcinoma.
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expression of Cortactin anti body in people with Urothelial Carcinoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment and correlating Cortactin expression in invasive and non-invasive urothelial carcinoma. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.