Clinicopathological Value of p16 Expression in Colorectal Carcinoma

NCT ID: NCT07047482

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-12-30

Brief Summary

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Evaluation of the immunohistochemical expression of p16 in colorectal carcinoma and correlate its expression to different clinical and pathological parameters as patients' ages, sexes, tumor location, histopathological phenotype, status of nodal involvement, perineural and lymphovascular invasion.

Detailed Description

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Colorectal Carcinoma is very common nowadays, with increasing need for further research.

p16 is tumor suppressor gene with a vital rule ; inactivation of p16 leads to tumor formation and progression.

50 Specimens will be collected from Pathology Department of Sohag University Hospital. Sufficient clinical and histopathological data will be attached for each case.

The previously processed formalin-fixed, paraffin-embedded tissue blocks will be used to get Hematoxylin \& Eosin stained sections to confirm the diagnosis and to detect the histopathological type, grade and stage of each tumor.

Another sliced tissue sections will be immunohistochemically stained with p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain.

Conditions

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Colorectal Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants

Fifty (50) cases of colorectal cancer will be performed from archieved formalin-fixed, paraffin-embedded tissue blocks referred to Pathology Department, Sohag University Hospitals.

Immunohistochemical staining

Intervention Type BIOLOGICAL

Immunohistochemical staining of paraffin embedded blocks of colorectal carcinoma tissues by p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain.

Interventions

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Immunohistochemical staining

Immunohistochemical staining of paraffin embedded blocks of colorectal carcinoma tissues by p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Specimens from patients with colorectal cancer.
2. Tissue blocks with sufficient material.
3. Specimens with sufficient clinical data.

Exclusion Criteria

1. Tissue blocks with insufficient, destroyed or necrotic material.
2. Specimens with insufficient clinical data.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Sherry Raouf Azmy

Demonstrator of pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Sohag, Recruiting, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherry R Azmy, Demonstrator of pathology

Role: CONTACT

01507557371 ext. 01207589093

Facility Contacts

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Magdy M Amin, Professor

Role: primary

Sherry R Azmy, Demonstrator of pathology

Role: backup

01507557371 ext. 01507557371

Other Identifiers

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Soh-Med--25-6-2MS

Identifier Type: -

Identifier Source: org_study_id

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