Bladder CancerNCT05799456
Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
An observational study of Bladder Cancer, run by Jens Nielsen at 1 site in Sweden.
Trial summary
Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Free glycosaminoglycan profiling
- How many people
- 106 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2018to 28 Feb 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective case-control study to compare patients elected for transurethral resection of the bladder (TURB) for bladder cancer (BCa) [cases] versus patients with no evidence of disease (NED) during the follow-up of previously localised BCa [controls].
Who may be able to join
- Primary BCa diagnosis at cystoscopy, planned for TURB
- In follow-up with cystoscopy after treatment Ta-T3 N0-2 M0 BCa or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion
- No history of cancer except urothelial
Who cannot join
- No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB
- Controls (No evidence of disease [NED])
- Positive cytology at inclusion visit
- Intravesical instillation therapy during 6 months prior to inclusion visit
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
Gothenburg
About this study
Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.
- Conditions
- Bladder Cancer
- Being tested
- Free glycosaminoglycan profiling
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free glycosaminoglycan profilingDiagnostic test
Free glycosaminoglycan profiling (GAGome) analysis was performed at a single blinded central laboratory using commercial kits wherein the concentration (in µg/mL) of 17 chondroitin sulfate (CS), heparan sulfate (HS), hyaluronic acid (HA) disaccharides were detected and quantified using a UHPLC-MS/MS system.
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer | Not described Receives: Diagnostic Test: Free glycosaminoglycan profiling | |
| No evidence of disease | Not described Receives: Diagnostic Test: Free glycosaminoglycan profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED
Measured: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Oct 2018
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Nielsen
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor-investigator, Jens Nielsen, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799456
- Sponsor's protocol ID
- GAG-BCa-001
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT05799456
- Acronym / sponsor ID
- GAG-BCa-001
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Jens NielsenUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 5 Apr 2023 (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.
Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer | – | Diagnostic Test: Free glycosaminoglycan profiling |
| No evidence of disease | – | Diagnostic Test: Free glycosaminoglycan profiling |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective case-control study to compare patients elected for transurethral resection of the bladder (TURB) for bladder cancer (BCa) [cases] versus patients with no evidence of disease (NED) during the follow-up of previously localised BCa [controls].
Key inclusion criteria (3 listed)
- Primary BCa diagnosis at cystoscopy, planned for TURB
- In follow-up with cystoscopy after treatment Ta-T3 N0-2 M0 BCa or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion
- No history of cancer except urothelial
Key exclusion criteria (4 listed)
- No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB
- Controls (No evidence of disease [NED])
- Positive cytology at inclusion visit
- Intravesical instillation therapy during 6 months prior to inclusion visit
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 |
|---|---|---|
| Free glycosaminoglycan profilingFree glycosaminoglycan profiling (GAGome) analysis was performed at a single blinded central laboratory using commercial kits wherein the concentration (in µg/mL) of 17 chondroitin sulfate (CS), heparan sulfate (HS), hyaluronic acid (HA) disaccharides were detected and quantified using a UHPLC-MS/MS system. | Diagnostic test | Bladder cancer, No evidence of disease |
Primary outcome
Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED
Time frame: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery
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 5 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Jens Nielsen at 1 site in Sweden.
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 4 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 5 Apr 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 Sweden. 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?
Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED (time frame: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery). 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 5 Apr 2023.