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NCT Number: NCT07047482

Clinicopathological Value of p16 Expression in Colorectal Carcinoma

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.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Sohag, Recruiting, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Specimens from patients with colorectal cancer.
  • Tissue blocks with sufficient material.
  • Specimens with sufficient clinical data.

Exclusion criteria

  • Tissue blocks with insufficient, destroyed or necrotic material.
  • Specimens with insufficient clinical data.

Treatment and study plan

Immunohistochemical staining

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.

Primary outcomes

  1. Evaluation of p16 Expression in Colorectal Carcinoma.

    Time frame: 6 months

    Immunohistochemical staining of Colorectal tissues by p16 monoclonal antibody

Secondary outcomes

  1. Correlation of p16 expression to different clinical and pathological parameters

    Time frame: 6 months

    Correlation of p16 expression to different clinical and pathological parameters as patients' ages, sexes, tumor location, histopathological phenotype, status of nodal involvement, perineural and lymphovascular invasion.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Clinicopathological Value of p16 Expression in Colorectal Carcinoma: An Immunohistochemical Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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