NCT04669951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

December 2, 2020

Last Update Submit

June 1, 2021

Conditions

Keywords

urokinase plasminogen activator receptoruPARCardiaAdenocarcinomaImmunohistochemistry

Outcome Measures

Primary Outcomes (2)

  • 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

  • Tumor-to-background ratio

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

    Up to 6 months

Secondary Outcomes (1)

  • uPAR in patient groups

    Up to 6 months

Study Arms (1)

uPAR expression

EXPERIMENTAL

Immunohistochemistry

Other: uPAR immunohistochemistry

Interventions

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

uPAR expression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Adenocarcinoma Of EsophagusAdenocarcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Michael Achiam, MD., Ph.D

    Rigshospitalet, Department of Surgical Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 17, 2020

Study Start

November 18, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

June 3, 2021

Record last verified: 2021-06

Locations