Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer

June 1, 2021 updated by: Michael Patrick Achiam

Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Adenocarcinomas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uPAR expression
Immunohistochemistry
Other: uPAR immunohistochemistry
Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uPAR microexpression
Time Frame: 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.
Up to 6 months
Tumor-to-background ratio
Time Frame: Up to 6 months
A pathology staining will determine the uPAR in the tumor compared with the healthy cells.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uPAR in patient groups
Time Frame: Up to 6 months
Baseline statistical analysis of patient groups and their expression of uPAR in their resected tumor tissues will be made.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Patrick Achiam

Investigators

  • Principal Investigator: Michael Achiam, MD., Ph.D, Rigshospitalet, Department of Surgical Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uPAR ECV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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