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CompletedNCT04669951Updated Jun 3, 2021

Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer

An interventional study of uPAR immunohistochemistry in Esophagus Cancer, Adenocarcinoma, sponsored by Michael Patrick Achiam. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-03.

Sponsored by Michael Patrick Achiam · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2019, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Esophagus Cancer, Adenocarcinoma

Keywords

  • urokinase plasminogen activator receptor
  • uPAR
  • Cardia
  • Adenocarcinoma
  • Immunohistochemistry
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 100 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Michael Patrick Achiam is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    uPAR expression

    Immunohistochemistry

    Other: uPAR immunohistochemistry

Interventions

  • OtheruPAR immunohistochemistry

    Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months

  2. Tumor-to-background ratio

    A pathology staining will determine the uPAR in the tumor compared with the healthy cells.

    Time frame: Up to 6 months

Secondary outcomes

  1. uPAR in patient groups

    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

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, Region Hovedstaden 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04669951
Lead sponsor
Michael Patrick Achiam
Responsible party
Michael Patrick Achiam (Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Dec 17, 2020
Start date
Nov 18, 2019
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
Jun 3, 2021

Study contacts

Michael Achiam, MD., Ph.D
principal investigator · Rigshospitalet, Department of Surgical Gastroenterology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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