Clinical trial Recruiting at 1 site Observational

p16 protein expression in colorectal cancer and its links to clinical and pathological features

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

Run by Sohag University · NCT07047482 · Data updated 2026-11-12

This project will test whether p16 protein levels and staining patterns in tumor tissue from people with colorectal cancer link to features such as age, tumor site, histologic type, lymph node status, and nerve or vessel invasion.

More Colorectal Carcinoma trials

Quick facts

Study typeObservational
SexAll
Enrollment50 (estimated)
SponsorSohag University
Academic / other
Locations1 site (Sohag, Recruiting)
StatusRecruiting
StartedMay 1, 2025
Main results expectedMarch 21, 2026
Study endsDecember 30, 2026
Registry record updatedJuly 10, 2025
Trial IDNCT07047482 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal specimens come from patients with confirmed colorectal carcinoma who have sufficient preserved tumor tissue in their paraffin blocks and accompanying clinical and histopathological information.

Probably not a fit

Specimens that are necrotic, depleted, or lack adequate clinical or histopathological data are not suitable and will not yield useful results for this work.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will use 50 archived colorectal cancer tissue blocks from the Pathology Department of Sohag University Hospital. Hematoxylin and eosin sections will confirm diagnosis, histopathological type, grade, and stage, and additional sections will be stained by immunohistochemistry for p16. Investigators will score p16 positivity, staining intensity, and distribution and correlate these measures with patients' age, sex, tumor location, histologic phenotype, nodal involvement, perineural invasion, and lymphovascular invasion. No interventions are given to patients; the work analyzes existing formalin-fixed, paraffin-embedded specimens with linked clinical data.

Why it matters

Potential benefit: If clear p16 patterns are linked to tumor behavior, p16 staining could help pathologists and clinicians better predict prognosis or refine treatment decisions.

How similar studies have gone: Immunohistochemical and molecular studies of p16 in colorectal cancer have been published with mixed and sometimes conflicting results, so the approach is established but not definitive.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Faculty of Medicine
    Sohag, Recruiting, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.