NCT05794737

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

March 20, 2023

Last Update Submit

March 20, 2023

Conditions

Keywords

Inhibin Beta AColorectal CarcinomaImmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between INHBA expression in Colorectal Carcinoma and clinicopathological parameters.

    6 months

Study Arms (1)

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

Interventions

Staining of Colorectal Carcinoma tissue sections by monoclonal antibodies against human Inhibin Beta A by immunohistochemical procedures.

Participants

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Specimens from patients with Colorectal Carcinoma. 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)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

60 formalin fixed, Paraffin embedded Colorectal Cancer tissue blocks.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mera A Fayez, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant of Pathology

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

January 1, 2021

Primary Completion

September 30, 2023

Study Completion

June 30, 2024

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations