Bladder CancerNCT05400291
Gag-layer in the Urothelium of the Human Upper Urinary Tract
An observational study of Bladder Cancer and Renal Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". Much of the current clinical decision-making surrounding Upper Tract Urothelial Carcinoma (UTUC) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Renal Cancer
- What is being tested?
- Chondroitin Sulfate Staining
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Patients undergoing cystectomy or nephrectomy
Who may be able to join
- Bladder cancer or renal cell carcinoma
- Ability to understand and sign informed consent form
Who cannot join
- Previous history of cancer
- Immune suppressing medication
- Treatment with local or systemic steroids (< 3 months prior to enrollment)
- Treatment with antibiotics due to urinary tract infection or pyelonephritis (< 3 months prior to enrollment)
- Previous radiation therapy of the pelvic floor
- Ureteric stent
- Dilatation of the upper urinary tract detected on imaging
- Dilatation of the upper urinary tract detected on imaging
Trial locations and contacts
1 site in 1 country.
About this study
Urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". Much of the current clinical decision-making surrounding Upper Tract Urothelial Carcinoma (UTUC) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients.
The inner wall of the bladder is coated with a substance called glycosaminoglycan (GAG). GAG is known to form a gel-like layer on the apical cell membrane and act as a barrier against urine and pathogens in the lower urinary tract.
Read more
Currently no published research on the presence of a GAG layer in the upper urinary tract exists. However, literature suggests that the ureteral utothelium can be transduced without enhancers, and the ureteral urothelium may be intrinsically different from bladder, both by the presence or absence of a GAG-layer, by different composition/thickness of the GAG-layer.
Any functional differences between the urothelial layers in the bladder and in the upper urinary tract may affect the adeno-virus transduction, which again will have potential impact on future treatment of UTUC patients with a current unmet medical need.
Read the detailed description
This study will include patients either undergoing radical nephrectomy or radical cystectomy. After organ removal during surgery a biopsi (1x1 cm) will be collected from the ureter and the renal pelvis or from the ureter and the bladder (depending on type of surgery).
These biopsies will be examined and compared, using molecular biotechniques, for the presence of glykosamino glykan (GAG) layer.
There is no project related follow up for patients included, other than what is standard post-operative regime in the department.
- Conditions
- Bladder Cancer, Renal Cancer
- Being tested
- Chondroitin Sulfate Staining
- Keywords
- glykosaminoglycan layer
- Medical subject headings
- Urinary Bladder Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin Sulfate StainingDiagnostic test
Staining of histopathological slides
| Study group | Role | What they receive |
|---|---|---|
| Renal Cell Carcinoma | patients undergoing radical nephrectomy because of renal clear cell carcinoma, tissue will be collected after the organ is removed. Receives: Diagnostic Test: Chondroitin Sulfate Staining | |
| Muscle Invasive Bladder Cancer | patients underoing radical cystectomi because of muscle-invasive bladder cancer, tissue will be collected after the organ is removed. Receives: Diagnostic Test: Chondroitin Sulfate Staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a GAG layer in the upper urinary tract
Number of specimens with presence of GAG layer by histopatological staining
Measured: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Secondary outcomes (1)
Thickness of the potential GAG layer in the upper urinary tract
Compare the morphological and histological features of a GAG layer in the upper urinary tract to that of the bladder
Measured: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Ventures
- Responsible party
- Principal investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
- Investigators
- Jørgen B Jensen, Dr. Med., Principal investigator, AUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400291
- Sponsor's protocol ID
- GAG
- Status last verified
- May 2023
- First submitted
- 21 Feb 2022
- Last updated
- 1 Jun 2023
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gag-layer in the Urothelium of the Human Upper Urinary Tract
- ClinicalTrials.gov ID
- NCT05400291
- Acronym / sponsor ID
- GAG
- Conditions
- Bladder Cancer, Renal Cancer
- Keywords
- glykosaminoglycan layer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Ferring Ventures
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Jun 2022 (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.
Urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". Much of the current clinical decision-making surrounding Upper Tract Urothelial Carcinoma (UTUC) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients.
The inner wall of the bladder is coated with a substance called glycosaminoglycan (GAG). GAG is known to form a gel-like layer on the apical cell membrane and act as a barrier against urine and pathogens in the lower urinary tract.
Currently no published research on the presence of a GAG layer in the upper urinary tract exists. However, literature suggests that the ureteral utothelium can be transduced without enhancers, and the ureteral urothelium may be intrinsically different from bladder, both by the presence or absence of a GAG-layer, by different composition/thickness of the GAG-layer.
Any functional differences between the urothelial layers in the bladder and in the upper urinary tract may affect the adeno-virus transduction, which again will have potential impact on future treatment of UTUC patients with a current unmet medical need.
Detailed description
This study will include patients either undergoing radical nephrectomy or radical cystectomy. After organ removal during surgery a biopsi (1x1 cm) will be collected from the ureter and the renal pelvis or from the ureter and the bladder (depending on type of surgery).
These biopsies will be examined and compared, using molecular biotechniques, for the presence of glykosamino glykan (GAG) layer.
There is no project related follow up for patients included, other than what is standard post-operative regime in the department.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Cell Carcinoma | – | Diagnostic Test: Chondroitin Sulfate Stainingpatients undergoing radical nephrectomy because of renal clear cell carcinoma, tissue will be collected after the organ is removed. |
| Muscle Invasive Bladder Cancer | – | Diagnostic Test: Chondroitin Sulfate Stainingpatients underoing radical cystectomi because of muscle-invasive bladder cancer, tissue will be collected after the organ is removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cystectomy or nephrectomy
Key inclusion criteria (2 listed)
- Bladder cancer or renal cell carcinoma
- Ability to understand and sign informed consent form
Key exclusion criteria (8 listed)
- Previous history of cancer
- Immune suppressing medication
- Treatment with local or systemic steroids (< 3 months prior to enrollment)
- Treatment with antibiotics due to urinary tract infection or pyelonephritis (< 3 months prior to enrollment)
- Previous radiation therapy of the pelvic floor
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 |
|---|---|---|
| Chondroitin Sulfate StainingStaining of histopathological slides | Diagnostic test | Muscle Invasive Bladder Cancer, Renal Cell Carcinoma |
Primary outcome
Identification of a GAG layer in the upper urinary tract
Time frame: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
Number of specimens with presence of GAG layer by histopatological staining
1 secondary outcome
Thickness of the potential GAG layer in the upper urinary tract
Time frame: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected
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 1 Jun 2023.
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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.
Jørgen B Jensen, Dr. Med. principal investigator
AUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Renal Cancer, run by Aarhus University Hospital 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 2 inclusion and 8 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 1 Jun 2023. 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?
Identification of a GAG layer in the upper urinary tract (time frame: samples are collected and stained immediately after the surgery, all samples will be compared and analyzed once all samples have been collected). 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 1 Jun 2023.