Clear Cell Renal Cell CarcinomaAUR87ANCT04006405
AURORAX-0087A: GAG Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic ccRCC
An observational study of Clear Cell Renal Cell Carcinoma, run by Elypta at 29 sites in 11 countries.
Trial summary
AUR87A is an observational prospective multicenter diagnostics test cohort study for detection of renal cell carcinoma recurrence as determined by the reference standard, which is imaging using computed tomography (CT) of the chest and abdomen at defined intervals after primary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- GAG score
- How many people
- 280 participants
- Where
- 29 sitesin 11 countries
- Study dates
- 10 Jan 2020to 7 May 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 population is a representative sample of the North American and European population of ccRCC patients with LP ≥ 5 after curative intent surgery
Who may be able to join
- Pre-screening inclusion criteria
- Size of primary tumor >4cm (>cT1a) in greatest dimension on pre-operative abdominal CT-scan
- Size of primary tumor ≤4cm is allowed if pre-operative abdominal CT-scan shows suspected RCCs with radiological sign of venous tumor thrombus (renal vein or caval).
- Pre-operative CT-scan of chest and abdomen show no signs of metastatic disease
- Localized and biopsy proven clear cell RCC (ccRCC) under active surveillance which at timepoint of study recruitment, opted for surgery because of growth rate of primary tumor to a size > 4cm
- Elected for curative intent surgery for RCC
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- Final screening inclusion criteria
- Any gender being 18 years or older at timepoint of final inclusion
- In postoperative pathology report shown to be ccRCC subtype according to 8th Edition of the American Joint Committee on Cancer (AJCC)
- Leibovich points (LP) ≥5 according to Leibovich score system (2003)
- If pathology report shows multiple subtypes in same tumor, as long as the majority of tumor is ccRCC (>50%), participant can be included
Who cannot join
- Pre-screening exclusion criteria
- TNM-stage T(any) N(any) M1 according to AJCC, i.e. metastatic disease at diagnosis
- Absence of preoperative chest imaging (chest CT) within 60 days prior to primary surgery
- Previous history of curatively treated for other cancers, still not deemed fully cured and participant still under surveillance for said cancer
- Participants offered active surveillance for RCC instead of curative intent surgery
- Participants offered any type of thermal ablation treatment instead of surgery, i.e. LP cannot be assessed
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- Final screening exclusion criteria
- Participants with AJCC cN0 status at preoperative imaging in whom a clinically suspicious regional lymph-node metastases (enlarged lymph node(s)) is noted during primary surgery, but who subsequently do not undergo any lymph node dissection. (Note: participants with cN0 status at pre-operative imaging and no clinical signs of regional lymph node metastases during primary surgery can still be included irrespective of lymph node dissection having been performed, i.e. being pN0 or pN1 if it is performed or pNx if it is not performed)
- Participants with AJCC cN1 status at pre-operative imaging in which lymph node dissection is not performed (i.e. pNx).
- Elected for any adjuvant therapy (i.e. systemic therapy) outside or within any clinical study
- Non-clear cell RCC histology or benign tumor (i.e. oncocytoma and angiomyolipoma, which are the most common benign types, but also any other rare types of benign renal tumors) after pathological analysis
- Any hereditary form of RCC (e.g. Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Papillary RCC)
- RCC with pure sarcomatoid differentiation, also called sarcoma of the kidney
- Previous history of curatively treated for RCC with a suspected de novo RCC in the remaining kidney tissue
- Prior or current use of instillation therapy with hyaluronic acid and/or chondroitin sulfate (HA-CS).
- Use of heparin, including low molecular weight heparin (e.g. Enoxaparin, Dalteparin, Tinzaparin) for concurrent disease in need of blood dilution (e.g. ongoing deep vein thrombosis or lung emboli). Note: use of of heparin for thrombus prophylaxis in conjunction with primary surgery or postoperatively ≤4 weeks will be allowed.
- Patients who were not radically operated during primary surgery with the exception of histological positive surgical margin in participants who have undergone partial nephrectomy.
Trial locations and contacts
29 sites in 11 countries.
29 sites in 11 countries
United Kingdom8 sites
Addenbrooke's Hospital
Cambridge
Western General Hospital
Edinburgh
Frimley Park Hospital
Frimley
Guys & St Thomas Hospital
London
Royal Free Hospital
London
Norfolk & Norwich University Hospital
Norwich
Royal Berkshire Hospital
Reading
Salford Royal NHS Foundation Trust
Salford
Italy6 sites
AOU San Orsola Malpighi
Bologna
Careggi University Hospital
Florence
San Raffaele Hospital
Milan
AOU San Luigi Gonzaga
Orbassano
Istituto Nazionale Tumori Regina Elena
Roma
AOU Integrata Verona
Verona
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Denmark3 sites
Aarhus University Hospital
Aarhus
Odense University Hospital
Odense
Zealand University Hospital
Roskilde
Spain2 sites
Hospital Universitario Cabueñes
Gijón
University Hospital of Valencia
Valencia
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Norrlands University Hospital
Umeå
About this study
Official title: AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic Clear Cell Renal Cell Carcinoma
AUR87A is an observational prospective multicenter diagnostics test cohort study for detection of renal cell carcinoma recurrence as determined by the reference standard, which is imaging using computed tomography (CT) of the chest and abdomen at defined intervals after primary surgery.
Read the detailed description
Non-metastatic clear cell renal cell carcinoma (ccRCC) recur in ~20% of cases within 5 years after radical surgery. Current postoperative follow-up protocols, being schematic and at best based on risk of recurrence scores, are sub-optimal for early detection of recurrences which could potentially be available for curative management. Blood and urine collected glycosaminoglycans (GAGs) are promising novel class of biomarkers from which a new diagnostic test based on so called GAG scores has been developed. GAG scores have accurately distinguished localized/locally-advanced and advanced RCC from healthy subjects.
AUR87A features an adaptive design. The primary endpoint analysis is conducted when 30 events (i.e. recurrences) are reached - expected at 140 patients with a minimum follow-up of 12 months (cohort 1). An interim analysis at 15 events is conducted to verify whether the sensitivity and specificity estimates are in line with the study assumptions. In case of futility, the GAG scores formulations and/or cut-offs are optimized based on data from cohort 1. The primary endpoints are then validated on a second independent cohort, powered depending on the results from cohort 1. This second cohort is estimated in 140 patients (cohort 2). In case of non-futility, cohort 2 may be used as external validation.
AUR87A will prospectively enroll an estimated 280 non-metastatic ccRCC patients curatively treated with surgery (partial or radical nephrectomy). Patients are followed-up longitudinally using GAG scores in blood and urine every 3 months after surgery, alongside the current standard follow-up protocol, i.e. imaging, as reference standard.
The hypothesis of AUR87A is that postoperative increase of the GAG scores, so called "GAG recurrence ", can predict or detect recurrence at an earlier time-point compared to the reference standard, referred to as "radiological recurrence", and thereby improve the clinical utility of current follow-up protocols.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- GAG score
- Medical subject headings
- Carcinoma, Renal Cell
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 | 140 patients with a minimum follow-up of 12 months Receives: Diagnostic Test: GAG score | |
| Cohort 2 | up to 140 patients with a minimum follow-up of 12 months Receives: Diagnostic Test: GAG score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of GAG recurrence
Sensitivity and specificity of GAG recurrence to LP≥5 ccRCC radiological or histologically verified recurrence with a minimum follow-up time of 12 months
Measured: minimum follow-up of 12 months
Secondary outcomes (7)
Absolute and relative risk increase (ARI/RRI) of radiological recurrence
Absolute and relative risk increase (ARI/RRI) of radiological recurrence in patients with GAG recurrence versus no GAG recurrence
Measured: within 6 months since last GAG score evaluation
Recurrence-free survival (RFS)
Recurrence-free survival (RFS) in the LP≥5 ccRCC for GAG recurrence vs. no GAG recurrence with a minimum follow-up time of 12 months
Measured: minimum follow-up of 12 months
Positive and negative predictive value (PPV/NPV) of GAG recurrence
Positive and negative predictive value (PPV/NPV) of GAG recurrence to LP ≥5 ccRCC radiological recurrence
Measured: minimum follow-up of 12 months
Area under the receiver-operating-characteristic curve (AUC) of GAG scores
Area under the receiver-operating-characteristic curve (AUC) of GAG scores to LP ≥5 ccRCC radiological recurrence
Measured: minimum follow-up of 12 months
RFS, overall survival (OS) and cancer specific survival (CSS)
RFS, overall survival (OS) and cancer specific survival (CSS) in patients with GAG recurrence versus no GAG recurrence
Measured: follow-up time of 2 years and 5 years respectively after primary surgery
Concordance-index (C-index) of preoperative GAG scores
Concordance-index (C-index) of preoperative GAG scores versus risk nomograms for RFS and for CSS
Measured: follow-up time of 2 years and 5 years respectively after primary surgery
Lead-time GAG vs. radiological recurrence among true positives
Lead-time GAG vs. radiological recurrence among true positives
Measured: minimum follow-up of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start10 Jan 2020
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elypta
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saeed Dabestani, Principal investigator, Lund University, Dept. Clinical Sciences, Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006405
- Sponsor's protocol ID
- ECD-AUR87A001
- Acronym
- AUR87A
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2019
- Last updated
- 15 Jun 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04006405
- Acronym / sponsor ID
- AUR87A / ECD-AUR87A001
- Conditions
- Clear Cell Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- ElyptaIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 5 Jul 2019 (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.
AUR87A is an observational prospective multicenter diagnostics test cohort study for detection of renal cell carcinoma recurrence as determined by the reference standard, which is imaging using computed tomography (CT) of the chest and abdomen at defined intervals after primary surgery.
Detailed description
Non-metastatic clear cell renal cell carcinoma (ccRCC) recur in ~20% of cases within 5 years after radical surgery. Current postoperative follow-up protocols, being schematic and at best based on risk of recurrence scores, are sub-optimal for early detection of recurrences which could potentially be available for curative management. Blood and urine collected glycosaminoglycans (GAGs) are promising novel class of biomarkers from which a new diagnostic test based on so called GAG scores has been developed. GAG scores have accurately distinguished localized/locally-advanced and advanced RCC from healthy subjects.
AUR87A features an adaptive design. The primary endpoint analysis is conducted when 30 events (i.e. recurrences) are reached - expected at 140 patients with a minimum follow-up of 12 months (cohort 1). An interim analysis at 15 events is conducted to verify whether the sensitivity and specificity estimates are in line with the study assumptions. In case of futility, the GAG scores formulations and/or cut-offs are optimized based on data from cohort 1. The primary endpoints are then validated on a second independent cohort, powered depending on the results from cohort 1. This second cohort is estimated in 140 patients (cohort 2). In case of non-futility, cohort 2 may be used as external validation.
AUR87A will prospectively enroll an estimated 280 non-metastatic ccRCC patients curatively treated with surgery (partial or radical nephrectomy). Patients are followed-up longitudinally using GAG scores in blood and urine every 3 months after surgery, alongside the current standard follow-up protocol, i.e. imaging, as reference standard.
The hypothesis of AUR87A is that postoperative increase of the GAG scores, so called "GAG recurrence ", can predict or detect recurrence at an earlier time-point compared to the reference standard, referred to as "radiological recurrence", and thereby improve the clinical utility of current follow-up protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: GAG score140 patients with a minimum follow-up of 12 months |
| Cohort 2 | – | Diagnostic Test: GAG scoreup to 140 patients with a minimum follow-up of 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a representative sample of the North American and European population of ccRCC patients with LP ≥ 5 after curative intent surgery
Key inclusion criteria (11 listed)
- Pre-screening inclusion criteria
- Size of primary tumor >4cm (>cT1a) in greatest dimension on pre-operative abdominal CT-scan
- Size of primary tumor ≤4cm is allowed if pre-operative abdominal CT-scan shows suspected RCCs with radiological sign of venous tumor thrombus (renal vein or caval).
- Pre-operative CT-scan of chest and abdomen show no signs of metastatic disease
- Localized and biopsy proven clear cell RCC (ccRCC) under active surveillance which at timepoint of study recruitment, opted for surgery because of growth rate of primary tumor to a size > 4cm
Key exclusion criteria (17 listed)
- Pre-screening exclusion criteria
- TNM-stage T(any) N(any) M1 according to AJCC, i.e. metastatic disease at diagnosis
- Absence of preoperative chest imaging (chest CT) within 60 days prior to primary surgery
- Previous history of curatively treated for other cancers, still not deemed fully cured and participant still under surveillance for said cancer
- Participants offered active surveillance for RCC instead of curative intent surgery
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, Cohort 2 |
Primary outcome
Sensitivity and specificity of GAG recurrence
Time frame: minimum follow-up of 12 months
Sensitivity and specificity of GAG recurrence to LP≥5 ccRCC radiological or histologically verified recurrence with a minimum follow-up time of 12 months
7 secondary outcomes
Absolute and relative risk increase (ARI/RRI) of radiological recurrence
Time frame: within 6 months since last GAG score evaluation
Recurrence-free survival (RFS)
Time frame: minimum follow-up of 12 months
Positive and negative predictive value (PPV/NPV) of GAG recurrence
Time frame: minimum follow-up of 12 months
Area under the receiver-operating-characteristic curve (AUC) of GAG scores
Time frame: minimum follow-up of 12 months
RFS, overall survival (OS) and cancer specific survival (CSS)
Time frame: follow-up time of 2 years and 5 years respectively after primary surgery
Concordance-index (C-index) of preoperative GAG scores
Time frame: follow-up time of 2 years and 5 years respectively after primary surgery
Lead-time GAG vs. radiological recurrence among true positives
Time frame: minimum follow-up of 12 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 15 Jun 2025.
- Official website for AURORAX-87ALink provided by the sponsor.
- 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.
Saeed Dabestani principal investigator
Lund University, Dept. Clinical Sciences, Skåne University Hospital
29 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clear Cell Renal Cell Carcinoma, run by Elypta at 29 sites in 11 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 11 inclusion and 17 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 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, Italy, United States, Denmark, Spain and 6 more countries. 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?
Sensitivity and specificity of GAG recurrence (time frame: minimum follow-up of 12 months). 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 15 Jun 2025.