Esophagus Cancer, AdenocarcinomaNCT04669951
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer
A study testing uPAR immunohistochemistry in people with Esophagus Cancer, Adenocarcinoma, run by Michael Patrick Achiam at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Adenocarcinoma
- What is being tested?
- uPAR immunohistochemistry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Nov 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- Patients who underwent curatively intended surgery for gastroesophageal cancer
- Patients who underwent surgery after 01-01-2016.
Who cannot join
- Patients who applied for an exception from medical research at the "National Registry of Tissue Use."
- Patients with other histological subtypes than adenocarcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Esophagus Cancer, Adenocarcinoma
- Being tested
- uPAR immunohistochemistry
- Keywords
- urokinase plasminogen activator receptor, uPAR, Cardia, Adenocarcinoma, Immunohistochemistry
- Medical subject headings
- Adenocarcinoma Of Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uPAR immunohistochemistryOther
Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression
| Study group | Role | What they receive |
|---|---|---|
| uPAR expression | Experimental | Immunohistochemistry Receives: Other: uPAR immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Tumor-to-background ratio
A pathology staining will determine the uPAR in the tumor compared with the healthy cells.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Nov 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus Cancer, AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Patrick Achiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Patrick Achiam, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael Achiam, MD., Ph.D, Principal investigator, Rigshospitalet, Department of Surgical Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669951
- Sponsor's protocol ID
- uPAR ECV
- Status last verified
- Jun 2021
- First submitted
- 2 Dec 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Adenocarcinomas
- ClinicalTrials.gov ID
- NCT04669951
- Acronym / sponsor ID
- uPAR ECV
- Conditions
- Esophagus Cancer, Adenocarcinoma
- Keywords
- urokinase plasminogen activator receptor, uPAR, Cardia, Adenocarcinoma, Immunohistochemistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Michael Patrick AchiamUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| uPAR expression | Experimental | Other: uPAR immunohistochemistryImmunohistochemistry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Patients who underwent curatively intended surgery for gastroesophageal cancer
- Patients who underwent surgery after 01-01-2016.
Key exclusion criteria (2 listed)
- Patients who applied for an exception from medical research at the "National Registry of Tissue Use."
- Patients with other histological subtypes than adenocarcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uPAR immunohistochemistryResected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression | Other | uPAR expression |
Primary outcome
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.
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.
1 secondary outcome
uPAR in patient groups
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Achiam, MD., Ph.D principal investigator
Rigshospitalet, Department of Surgical Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uPAR immunohistochemistry in people with Esophagus Cancer, Adenocarcinoma, run by Michael Patrick Achiam at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uPAR microexpression (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.