Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer

Esophagus Cancer, Adenocarcinoma Clinical Trial

Official title:

Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Adenocarcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669951
• Other study ID #: uPAR ECV
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Esophagus Cancer, Adenocarcinoma

Intervention

Other:
• uPAR immunohistochemistry
Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Michael Patrick Achiam

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uPAR microexpression	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
Primary	Tumor-to-background ratio	A pathology staining will determine the uPAR in the tumor compared with the healthy cells.	Up to 6 months
Secondary	uPAR in patient groups	Baseline statistical analysis of patient groups and their expression of uPAR in their resected tumor tissues will be made.	Up to 6 months