Immunohistochemical Expression of Inhibin Beta A (INHBA) in Colorectal Carcinoma

A retrospective observational study to evaluate immunohistochemical expression of Inhibin Beta A (INHBA) in 60 cases of Colorectal Carcinoma, and compare levels of its expression to different clinicopathological criteria.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: Immunohistochemical staining

Detailed Description

Colorectal Carcinoma is an aggressive malignant epithelial tumor with an observable high incidence. Tumor invasion and metastasis to distant sites are two important issues which determine patient's outcome, so detecting novel biological markers that are involved in tumor proliferation and invasion with subsequent targeting by future medical drugs will positively improve patient's prognosis.

Inhibin Beta A (INHBA) is a glycoprotein molecule that has a role in tumor cells proliferation and invasion in different human malignancies. The aim of this study is to detect expression of INHBA in 60 archived formalin-fixed Paraffin-embedded tissue blocks of patients suffered from Colorectal Carcinoma, and to correlate different levels of its expression to some studied clinical and pathological criteria (Age, Sex, Tumor size, location, depth of tumor invasion, status of regional lymph nodes, vascular and perineural invasion).

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Mera A Fayez, Doctor; Phone Number: 01224890136; Email: meraatef@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospitals
    • Contact: Mera A Fayez, Doctor; Phone Number: 01224890136; Email: meraatef@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Archived Formalin-fixed, Paraffin-embedded tissue blocks belonged to patients suffered from colonic and/or rectal cancers. Patients were admitted to sohag university hospital and underwent colectomy and their colonic specimens were sent to Pathology Laboratory of the same hospital to ascertain diagnosis and tumor phenotype, from period Janurary 2021 to December 2022.

Description

Inclusion Criteria:

Specimens from patients with Colorectal Carcinoma. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; 60 archived Formalin-fixed Paraffin-embedded tissue blocks of Colorectal Carcinoma will be obtained and sectioned. From each block; Two tissue sections will be prepared, one tissue section will be stained by Hematoxylin and Eosin to detect tumor phenotype and depth of invasion. Other tissue section will be immunohistochemically stained by Anti-Human INHBA.	Biological: Immunohistochemical staining; Staining of Colorectal Carcinoma tissue sections by monoclonal antibodies against human Inhibin Beta A by immunohistochemical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of INHBA in Colorectal Carcinoma.	Detection of expression of INHBA in Colorectal Carcinoma cells by immunohistochemical approach, using anti-human INHBA monoclonal antibody.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between INHBA expression in Colorectal Carcinoma and clinicopathological parameters.	Correlation between different levels of INHBA expression in Colorectal Carcinoma cells and some clinical and pathological parameters as age, sex, tumor phenotype and nodal status.	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Immunohistochemistry; Colorectal Carcinoma; Inhibin Beta A
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Carcinoma; Colorectal Neoplasms
• Other Study ID Numbers: Soh-Med-23-03-08MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No