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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04006405




Registration number
NCT04006405
Ethics application status
Date submitted
1/07/2019
Date registered
5/07/2019
Date last updated
15/06/2025

Titles & IDs
Public title
AURORAX-0087A: GAG Scores for Surveillance of Recurrence in Leibovich Points =5 Non-metastatic ccRCC
Scientific title
AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points =5 Non-metastatic Clear Cell Renal Cell Carcinoma
Secondary ID [1] 0 0
ECD-AUR87A001
Universal Trial Number (UTN)
Trial acronym
AUR87A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - GAG score

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


Diagnosis / Prognosis: GAG score
blood and urine samples to determine GAG scores
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and specificity of GAG recurrence
Timepoint [1] 0 0
minimum follow-up of 12 months
Secondary outcome [1] 0 0
Absolute and relative risk increase (ARI/RRI) of radiological recurrence
Timepoint [1] 0 0
within 6 months since last GAG score evaluation
Secondary outcome [2] 0 0
Recurrence-free survival (RFS)
Timepoint [2] 0 0
minimum follow-up of 12 months
Secondary outcome [3] 0 0
Positive and negative predictive value (PPV/NPV) of GAG recurrence
Timepoint [3] 0 0
minimum follow-up of 12 months
Secondary outcome [4] 0 0
Area under the receiver-operating-characteristic curve (AUC) of GAG scores
Timepoint [4] 0 0
minimum follow-up of 12 months
Secondary outcome [5] 0 0
RFS, overall survival (OS) and cancer specific survival (CSS)
Timepoint [5] 0 0
follow-up time of 2 years and 5 years respectively after primary surgery
Secondary outcome [6] 0 0
Concordance-index (C-index) of preoperative GAG scores
Timepoint [6] 0 0
follow-up time of 2 years and 5 years respectively after primary surgery
Secondary outcome [7] 0 0
Lead-time GAG vs. radiological recurrence among true positives
Timepoint [7] 0 0
minimum follow-up of 12 months

Eligibility
Key inclusion criteria
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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2025
Sample size
Target
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Canada
State/province [5] 0 0
Calgary
Country [6] 0 0
Denmark
State/province [6] 0 0
Aarhus
Country [7] 0 0
Denmark
State/province [7] 0 0
Odense
Country [8] 0 0
Denmark
State/province [8] 0 0
Roskilde
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
France
State/province [10] 0 0
Créteil
Country [11] 0 0
Italy
State/province [11] 0 0
Bologna
Country [12] 0 0
Italy
State/province [12] 0 0
Florence
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Italy
State/province [14] 0 0
Orbassano
Country [15] 0 0
Italy
State/province [15] 0 0
Roma
Country [16] 0 0
Italy
State/province [16] 0 0
Verona
Country [17] 0 0
Portugal
State/province [17] 0 0
Coimbra
Country [18] 0 0
Spain
State/province [18] 0 0
Gijón
Country [19] 0 0
Spain
State/province [19] 0 0
Valencia
Country [20] 0 0
Sweden
State/province [20] 0 0
Gothenburg
Country [21] 0 0
Sweden
State/province [21] 0 0
Umeå
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Cambridge
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Edinburgh
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Frimley
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Norwich
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Reading
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Elypta
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Saeed Dabestani
Address 0 0
Lund University, Dept. Clinical Sciences, Skåne University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04006405