Back to resultsUrokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer
Primary Purpose
Esophagus Cancer, Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
uPAR immunohistochemistry
Sponsored by
About this trial
This is an interventional other trial for Esophagus Cancer, Adenocarcinoma focused on measuring urokinase plasminogen activator receptor, uPAR, Cardia, Adenocarcinoma, Immunohistochemistry
Eligibility Criteria
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.
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
uPAR expression
Arm Description
Immunohistochemistry
Outcomes
Primary Outcome Measures
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.
Tumor-to-background ratio
A pathology staining will determine the uPAR in the tumor compared with the healthy cells.
Secondary Outcome Measures
uPAR in patient groups
Baseline statistical analysis of patient groups and their expression of uPAR in their resected tumor tissues will be made.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04669951
Brief Title
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer
Official Title
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Adenocarcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Patrick Achiam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Adenocarcinoma
Keywords
urokinase plasminogen activator receptor, uPAR, Cardia, Adenocarcinoma, Immunohistochemistry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The patients will be drawn from the existing clinical biobank. The biobank is located at the department of pathology, Rigshospitalet. From this clinical biobank, a new temporary research biobank will be made. Supplementary sections from formalin-fixed paraffin embedded (FFPE) blocks containing tumor tissue will be cut and Haematoxylin and eosin (HE) and immunohistochemical (IHC) staining will be performed.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uPAR expression
Arm Type
Experimental
Arm Description
Immunohistochemistry
Intervention Type
Other
Intervention Name(s)
uPAR immunohistochemistry
Intervention Description
Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression
Primary Outcome Measure Information:
Title
uPAR microexpression
Description
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.
Time Frame
Up to 6 months
Title
Tumor-to-background ratio
Description
A pathology staining will determine the uPAR in the tumor compared with the healthy cells.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
uPAR in patient groups
Description
Baseline statistical analysis of patient groups and their expression of uPAR in their resected tumor tissues will be made.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Achiam, MD., Ph.D
Organizational Affiliation
Rigshospitalet, Department of Surgical Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Region Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer
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