AURORAX-0087A: GAG Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic ccRCC
AUR87A
AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic Clear Cell Renal Cell Carcinoma
1 other identifier
observational
280
11 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2025
CompletedJune 15, 2025
June 1, 2025
5.3 years
July 1, 2019
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
minimum follow-up of 12 months
Secondary Outcomes (7)
Absolute and relative risk increase (ARI/RRI) of radiological recurrence
within 6 months since last GAG score evaluation
Recurrence-free survival (RFS)
minimum follow-up of 12 months
Positive and negative predictive value (PPV/NPV) of GAG recurrence
minimum follow-up of 12 months
Area under the receiver-operating-characteristic curve (AUC) of GAG scores
minimum follow-up of 12 months
RFS, overall survival (OS) and cancer specific survival (CSS)
follow-up time of 2 years and 5 years respectively after primary surgery
- +2 more secondary outcomes
Study Arms (2)
Cohort 1
140 patients with a minimum follow-up of 12 months
Cohort 2
up to 140 patients with a minimum follow-up of 12 months
Interventions
Eligibility Criteria
The study population is a representative sample of the North American and European population of ccRCC patients with LP ≥ 5 after curative intent surgery
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elyptalead
Study Sites (29)
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
UZ Leuven
Leuven, Belgium
Prostate Cancer Centre
Calgary, Canada
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Hôpital Henri Mondor
Créteil, France
AOU San Orsola Malpighi
Bologna, Italy
Careggi University Hospital
Florence, Italy
San Raffaele Hospital
Milan, Italy
AOU San Luigi Gonzaga
Orbassano, Italy
Istituto Nazionale Tumori Regina Elena
Roma, Italy
AOU Integrata Verona
Verona, Italy
Hospital da Luz Coimbra
Coimbra, Portugal
Hospital Universitario Cabueñes
Gijón, Spain
University Hospital of Valencia
Valencia, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Norrlands University Hospital
Umeå, Sweden
Addenbrooke's Hospital
Cambridge, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Frimley Park Hospital
Frimley, United Kingdom
Guys & St Thomas Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Norfolk & Norwich University Hospital
Norwich, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Salford Royal NHS Foundation Trust
Salford, United Kingdom
Related Links
Biospecimen
blood and urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saeed Dabestani
Lund University, Dept. Clinical Sciences, Skåne University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
January 10, 2020
Primary Completion
May 7, 2025
Study Completion
May 7, 2025
Last Updated
June 15, 2025
Record last verified: 2025-06