NCT07047482

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2025Dec 2026

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 24, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

p16 ExpressionColorectal CarcinomaImmunohistochemical study

Outcome Measures

Primary Outcomes (1)

  • Evaluation of p16 Expression in Colorectal Carcinoma.

    Immunohistochemical staining of Colorectal tissues by p16 monoclonal antibody

    6 months

Secondary Outcomes (1)

  • Correlation of p16 expression to different clinical and pathological parameters

    6 months

Study Arms (1)

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.

Biological: Immunohistochemical staining

Interventions

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.

Participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Sohag, Recruiting, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Sherry R Azmy, Demonstrator of pathology

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of pathology

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

May 1, 2025

Primary Completion

March 21, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations