Muscle-Invasive Bladder CarcinomaAUR93ANCT05028660
AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study
An observational study of Muscle-Invasive Bladder Carcinoma, run by Elypta at 5 sites in 3 countries.
Trial summary
AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- GAG score
- How many people
- 43 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 21 Jul 2021to 30 Apr 2025
- 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: The study will enroll patients with MIBC elected for NAC, defined as: * MIBC: pathologically confirmed transitional cell carcinoma of the bladder with the invasion of the bladder muscular wall and no evidence of regional or distal metastases (T2-T4a cN0-N2 M0) * NAC: any choice of cisplatin-containing chemotherapeutic regimen.
Who may be able to join
- Histologically confirmed diagnosis of transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant [50%+] histology)
- Clinical stage T2-T4a N0-N2 M0 by CT (or MRI) + PET/CT
- Elected and fit according to institutional guidelines for cisplatin-based NAC followed by RC
- ECOG score 0-1
Who cannot join
- Previously intravenous chemotherapy for bladder cancer. (Patients who have had previous radiotherapy or concurrent chemo-radiation for bladder cancer are still eligible.)
- Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose NAC
- Known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- (A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower, Gleason score less/equal to 7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year before study allocation. Pathological evidence of concurrent T1a/b prostate cancer after radical cystecto-prostatectomy are still eligible.)
- Evidence of measurable nodal or metastatic disease.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy3 sites
AOU Careggi
Florence
IRCCS Ospedale San Raffaele, San Raffaele Hospital
Milan
IRCCS Regina Elena
Rome
About this study
Official title: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study
AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC).
Read the detailed description
There are around 200 000 cases of bladder cancer (BCa) in the EU every year. Of these, about 25% are diagnosed at a late stage wherein cancer has invaded the muscular wall. The survival of patients with muscle-invasive bladder cancer (MIBC) largely depends on the response to disease management, which in turn is likely dependent on the biology underlying different subtypes of MIBC.
The standard treatment is radical cystectomy (RC) and eligible patients are offered neo-adjuvant chemotherapy (NAC). However, only 30% of these patients report a complete response. Even though the response to NAC is likely correlated to the underlying tumor biology (for example, the TP53-like MIBC subtype is associated with a higher frequency of resistance to NAC), there are today no approved biomarkers to select patients likely to benefit from NAC. This information could in turn translate into more precise and personalized treatment for the patient.
In a proof-of-concept prospective study, we discovered that the profiling of urine and plasma glycosaminoglycans (GAGs) could be useful for the diagnosis and prognosis of BCa. AUR93A is a prospective single-arm cohort exploratory study. A sample size of approx. 47 patients with MIBC and elected for NAC will be included in this study and it is assumed that 30% will experience complete response at the post-operative visit. The goal is to correlate baseline (pre-NAC) GAGs to complete response rate (CRR) after RC and recurrence-free survival (RFS).
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- GAG score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAG scoreDiagnostic test
blood and urine samples to determine GAG scores
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Sample size of approximately 47 patients with MIBC and elected for NAC Receives: Diagnostic Test: GAG score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete response at the post-operative visit after RC.
Percentage point difference in complete response rates between GAG favorable and GAG poor patients
Measured: 15 to 90 days after radical cystectomy surgery
Secondary outcomes (2)
Proportion of patients with recurrence at any time after treatment
Percentage point difference in recurrence rates between GAG favorable and GAG poor patients
Measured: 15 to 90 days after radical cystectomy surgery
Proportion of complete responses after NAC according to CT-based RECIST v1.1
Percentage point difference in complete response rates after NAC between GAG favorable and GAG poor patients
Measured: 15 to 90 days after radical cystectomy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start21 Jul 2021
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elypta
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Francesco Gatto, Study director, Elypta, Solna, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028660
- Sponsor's protocol ID
- ECD-AUR93A001
- Acronym
- AUR93A
- Status last verified
- Apr 2025
- First submitted
- 25 Aug 2021
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Unidentified clinical and biochemical data will become available to the research community along with the publication of a scientific article related to the present investigation.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study
- ClinicalTrials.gov ID
- NCT05028660
- Acronym / sponsor ID
- AUR93A / ECD-AUR93A001
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- ElyptaIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 31 Aug 2021 (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.
AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC).
Detailed description
There are around 200 000 cases of bladder cancer (BCa) in the EU every year. Of these, about 25% are diagnosed at a late stage wherein cancer has invaded the muscular wall. The survival of patients with muscle-invasive bladder cancer (MIBC) largely depends on the response to disease management, which in turn is likely dependent on the biology underlying different subtypes of MIBC.
The standard treatment is radical cystectomy (RC) and eligible patients are offered neo-adjuvant chemotherapy (NAC). However, only 30% of these patients report a complete response. Even though the response to NAC is likely correlated to the underlying tumor biology (for example, the TP53-like MIBC subtype is associated with a higher frequency of resistance to NAC), there are today no approved biomarkers to select patients likely to benefit from NAC. This information could in turn translate into more precise and personalized treatment for the patient.
In a proof-of-concept prospective study, we discovered that the profiling of urine and plasma glycosaminoglycans (GAGs) could be useful for the diagnosis and prognosis of BCa. AUR93A is a prospective single-arm cohort exploratory study. A sample size of approx. 47 patients with MIBC and elected for NAC will be included in this study and it is assumed that 30% will experience complete response at the post-operative visit. The goal is to correlate baseline (pre-NAC) GAGs to complete response rate (CRR) after RC and recurrence-free survival (RFS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: GAG scoreSample size of approximately 47 patients with MIBC and elected for NAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients with MIBC elected for NAC, defined as: * MIBC: pathologically confirmed transitional cell carcinoma of the bladder with the invasion of the bladder muscular wall and no evidence of regional or distal metastases (T2-T4a cN0-N2 M0) * NAC: any choice of cisplatin-containing chemotherapeutic regimen.
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant [50%+] histology)
- Clinical stage T2-T4a N0-N2 M0 by CT (or MRI) + PET/CT
- Elected and fit according to institutional guidelines for cisplatin-based NAC followed by RC
- ECOG score 0-1
Key exclusion criteria (5 listed)
- Previously intravenous chemotherapy for bladder cancer. (Patients who have had previous radiotherapy or concurrent chemo-radiation for bladder cancer are still eligible.)
- Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose NAC
- Known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- (A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower, Gleason score less/equal to 7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year before study allocation. Pathological evidence of concurrent T1a/b prostate cancer after radical cystecto-prostatectomy are still eligible.)
- Evidence of measurable nodal or metastatic disease.
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 |
|---|---|---|
| GAG scoreblood and urine samples to determine GAG scores | Diagnostic test | Cohort 1 |
Primary outcome
Proportion of patients with complete response at the post-operative visit after RC.
Time frame: 15 to 90 days after radical cystectomy surgery
Percentage point difference in complete response rates between GAG favorable and GAG poor patients
2 secondary outcomes
Proportion of patients with recurrence at any time after treatment
Time frame: 15 to 90 days after radical cystectomy surgery
Proportion of complete responses after NAC according to CT-based RECIST v1.1
Time frame: 15 to 90 days after radical cystectomy 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 9 May 2025.
- Individual participant dataSharing planned: Undecided. Unidentified clinical and biochemical data will become available to the research community along with the publication of a scientific article related to the present investigation.
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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.
Francesco Gatto study director
Elypta, Solna, Sweden
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma, run by Elypta at 5 sites in 3 countries.
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 4 inclusion and 5 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 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Denmark, 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?
Proportion of patients with complete response at the post-operative visit after RC. (time frame: 15 to 90 days after radical cystectomy 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 9 May 2025.