p16 protein expression in colorectal cancer and its links to clinical and pathological features
Clinicopathological Value of p16 Expression in Colorectal Carcinoma: An Immunohistochemical Study.
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag, Recruiting) |
| Trial ID | NCT07047482 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sohag, Recruiting
- Faculty of Medicine — Sohag, Recruiting, Egypt (Recruiting)
Study contacts
- Study coordinator: Sherry R Azmy, Demonstrator of pathology
- Email: shery.raoof@med.sohag.edu.eg
- Phone: 01507557371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.