- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05225870
Significance of Cortactin Expression in Colorectal Adenocarcinomas
July 13, 2022 updated by: Maisa Hashem Mohammed, Sohag University
Enhanced Cortactin Expression is Associated With Increased Tumor Invasiveness and Nodal Metastasis in Egyptian Patients With Colorectal Adenocarcinomas
Colorectal carcinoma is one of the most aggressive malignant epithelial neoplasms affecting the gastrointestinal tract.
The incidence of colorectal carcinoma is obviously increasing in developing countries, where the physical inactivity and the consumption of animal fat-rich food became more evident.
Colorectal tumorigenesis is a multistep process which is initiated by adenoma and is terminated by carcinoma, the latter shows variable degrees of tumor differentiation and invasiveness.
During the adenoma-carcinoma process; a series of genetic mutations occur.
Detection of these genetic mutations will help in the development of novel therapeutic agents, which in turn will improve patients' outcomes.
Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11.
CTTN binds to and activates Arp 2/3 and stabilizes the dynamic actin assembly after its formation.
So, it become clear that CTTN is involved in the formation of the leading-edges cellular protrusions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Colorectal carcinoma is a highly lethal malignant epithelial tumor involving humans.
The incidence of colorectal carcinoma is steadily increasing in developing countries, this could be assigned to low physical activity together with high consumption of animal fat-rich food.
malignancy of the colon is a multistep process which is initiated by adenoma that proceeds to carcinoma, the latter includes a wide variety of tumor phenotypes.
During the adenoma-carcinoma process; a series of genetic and epigenetic alterations occur.
Detection of these genetic alterations is of great benefit in the future management of colorectal carcinomas.
Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11.
CTTN anchors the dynamic actin assembly .
CTTN is implicated in the formation of the leading-edges cellular protrusions.the
aim of this study is to evaluate expression of CTTN in 50 cases of colorectal adenocarcinomas and their adjacent normal colonic mucosae.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sohag, Egypt, 82524
- Maisa Hashem Mohammed
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with colorectal carcinomas who underwent colectomy operations.
Exclusion Criteria:
- specimens obtained by lower endoscopy only, patients who received pre-operative chemotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: patients with colorectal carcinoma
patients with colorectal carcinoma will undergo colectomy.
their colectomy specimens will be sectioned, tissue blocks will be prepared from tumor and adjacent normal mucosa.
sections will be stained immunohistochemically by antibody against cortactin.
|
sections from colorectal carcinoma will be immunohistochemically stained by anti-Cortactin antobody.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
immunohistochemical evaluation of Cortactin expression
Time Frame: 8 weeks
|
Fifty patients with colorectal adenocarcinoma will be enrolled in the study.
Formalin-fixed and paraffin embedded tissue blocks will be prepared from the tumor and adjacent normal colorectal mucosa in the Pathology lab.
Sections will be stained by Hematoxalin and Eosin to diagnose the tumor phenotype.
Additional sections will be mounted on coated slides and stained immunohistochemically by antibodies against human Cortactin .
immunohistochemical expression of Cortactin will be evaluated in both the tumor sections and adjacent normal mucosa by using Immuno-reactive score.
Expression of Cortactin in tumor tissues will be statistically correlated to degree of tumor differentiation, tumor invasion and nodal metastasis.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maisa H Mohammed, a lecturer of pathology, Sohag faculty of medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
January 23, 2022
First Submitted That Met QC Criteria
February 2, 2022
First Posted (Actual)
February 7, 2022
Study Record Updates
Last Update Posted (Actual)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 13, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-22-01-33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.