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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag, Recruiting) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | March 21, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07047482 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
- Study coordinator: Sherry R Azmy, Demonstrator of pathology
- Email: shery.raoof@med.sohag.edu.eg
- Phone: 01507557371
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exercise after pelvic radiation to see if it lowers colorectal cancer risk
This study tests whether regular walking therapy after pelvic radiation for prostate cancer can influence markers of colorectal cancer in colon tissue and blood.
-
Irreversible Electroporation for Recurrent Pelvic Tumors
This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.
-
Smart Symptom Tracking with ALEX for GI Health in Young Adults
This trial tests whether the Smart Symptom Tracking ALEX app can better track GI symptoms in young adults (18–44) compared with standard paper logs.
-
Culturally adapted online genetic counseling and testing education for African American cancer survivors
We will test a culturally adapted online genetic counseling program to see if it increases genetic counseling and genetic testing among African American breast, prostate, and colorectal cancer survivors.
-
Zanidatamab given before surgery for HER2-positive colon or rectal cancer
This tests whether giving zanidatamab before surgery helps adults with HER2-positive, RAS‑wildtype colon or rectal cancer who are planned for curative treatment.
-
In-home cancer treatment with remote specialist support for patients in the Florida Panhandle
This program will try giving standard cancer treatments at home to people living in the Florida Panhandle and nearby areas to see if they prefer it and have better treatment satisfaction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.