NCT05225870

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

January 23, 2022

Last Update Submit

July 13, 2022

Conditions

Keywords

cancer colonCortactinImmnuohistochemistry

Outcome Measures

Primary Outcomes (1)

  • immunohistochemical evaluation of Cortactin expression

    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

Study Arms (1)

patients with colorectal carcinoma

OTHER

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.

Genetic: immunohistochemical staining

Interventions

sections from colorectal carcinoma will be immunohistochemically stained by anti-Cortactin antobody.

patients with colorectal carcinoma

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with colorectal carcinomas who underwent colectomy operations.

You may not qualify if:

  • specimens obtained by lower endoscopy only, patients who received pre-operative chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisa Hashem Mohammed

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Maisa H Mohammed

    a lecturer of pathology, Sohag faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Fifty, paired formalin-fixed and paraffin embedded tissue blocks from the colorectal carcinomas and adjacent non neoplastic colonic mucosa will be prepared and sectioned. From each block; one section will be stained by Haematoxaline and Eosine to establish diagnosis of colorectal carcinomas and to determine the degree of differentiation and degree of invasion of the underlying colonic tissues. Corresponding sections from each Formalin-fixed paraffin embedded tissue blocks will be immunohistochemically stained by anti- Human Cortactin antibody, to detect any association between cortactin expression and colorectal carcinoma.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pathology

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 7, 2022

Study Start

January 1, 2021

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations