Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer

Not Applicable

Completed

• Conditions: Esophagus Cancer, Adenocarcinoma

• Registration Number: NCT04669951
• Lead Sponsor: Michael Patrick Achiam

Brief Summary

The aim of this study is to investigate urokinase Plasminogen Activator Receptor (uPAR) microexpression in gastroesophageal cancer (adenocarcinomas) both qualitatively and semi-quantitatively and to evaluate if it offers a possibility for future imagining purposes.

Detailed Description

* Sections of the tumor tissue will be HE stained.

* Sections of the tumor tissue will be stained with an uPAR antibody for immunohistochemistry.

* Immunohistochemical staining against cytokeratin which colors cancer cells will be made to assist the observer in the evaluation of uPAR microexpression pattern.

* A semiqualitative scale corresponding to the level of uPAR expression will be made.

* Quantitative polymerase chain reaction will be used to validate the immunohistochemistry uPAR expression pattern.

* An electronic scoring system (digital pathology) will be trained to access the expression of uPAR in both tumor- and normal tissue.

Study Timeline

• Study Start: 2019-11-18
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-17
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥18 years old.
• Patients who underwent curatively intended surgery for gastroesophageal cancer
• Patients who underwent surgery after 01-01-2016.

Exclusion Criteria

• Patients who applied for an exception from medical research at the "National Registry of Tissue Use."
• Patients with other histological subtypes than adenocarcinoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
uPAR microexpression	Up to 6 months	Our primary objective is to investigate uPAR microexpression in gastroesophageal adenocarcinomas both qualitatively and semi-quantitatively. This will be done by a pathology analysis of gastroesophageal cancer resections.
Tumor-to-background ratio	Up to 6 months	A pathology staining will determine the uPAR in the tumor compared with the healthy cells.

Secondary Outcome Measures

Name	Time	Method
uPAR in patient groups	Up to 6 months	Baseline statistical analysis of patient groups and their expression of uPAR in their resected tumor tissues will be made.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Region Hovedstaden, Denmark