Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate- and High-risk Nonmetastatic Clear Cell Renal Cell Carcinoma-An Observational Prospective Multicentre Diagnostic Test Cohort Study
(2025) In European Urology Oncology- Abstract
BACKGROUND AND OBJECTIVE: Nonmetastatic (M0) clear cell renal cell carcinoma (ccRCC) recurs in ∼20% of patients within 5 yr after surgery. With no biomarkers available, recurrence detection relies on radiological imaging. Urine glycosaminoglycan profiles (GAGomes) were previously associated with M0 ccRCC recurrence. We conducted an observational prospective multicentre diagnostic test cohort study to evaluate GAGomes for postsurgery recurrence detection in M0 ccRCC.
METHODS: Postsurgical M0 ccRCC patients with a Leibovich score of ≥5 points were included. Follow-up imaging up to 18 mo assessed radiological recurrence (reference standard). Urine GAGomes were measured every 3 mo to compute a GAGome score (index test). Sensitivity... (More)
BACKGROUND AND OBJECTIVE: Nonmetastatic (M0) clear cell renal cell carcinoma (ccRCC) recurs in ∼20% of patients within 5 yr after surgery. With no biomarkers available, recurrence detection relies on radiological imaging. Urine glycosaminoglycan profiles (GAGomes) were previously associated with M0 ccRCC recurrence. We conducted an observational prospective multicentre diagnostic test cohort study to evaluate GAGomes for postsurgery recurrence detection in M0 ccRCC.
METHODS: Postsurgical M0 ccRCC patients with a Leibovich score of ≥5 points were included. Follow-up imaging up to 18 mo assessed radiological recurrence (reference standard). Urine GAGomes were measured every 3 mo to compute a GAGome score (index test). Sensitivity and specificity to radiological recurrence were calculated. The lead time between the first positive GAGome score and radiological recurrence was estimated. Bayesian joint modelling estimated recurrence-free survival hazard ratio (HR).
KEY FINDINGS AND LIMITATIONS: Of the 393 patients screened (January 2020 to November 2021), 134 met the inclusion criteria. The median follow-up was 16 mo (interquartile range [IQR]: 12-18) for those without recurrence. At the last follow-up visit, 16% had recurred. The GAGome score had 90% sensitivity (95% confidence interval [CI]: 62-100%) and 51% specificity (95% CI: 30-71%) to radiological recurrence. The positive and negative predictive values were 26% (95%CI: 4-46%) and 97% (95% CI: 87-100%), respectively. The median lead time was 4.2 mo (IQR: 1.6-6.4). A 10-point GAGome score increase was associated with an HR of 1.62 (95% high density interval: 1.11-2.30) for recurrence. The main limitation was short follow-up time.
CONCLUSIONS AND CLINICAL IMPLICATIONS: GAGome score had very high sensitivity to ccRCC recurrence, resulting in a negative predictive value of 97%. External validation foreseen in the study design aims to confirm its utility to personalise follow-up for M0 ccRCC patients.
(Less)
- author
- Dabestani, Saeed
LU
; Azawi, Nessn H
; Campi, Riccardo
; Järvinen, Petrus
; Nisen, Harry
; Capitanio, Umberto
; Nielsen, Tommy Kjærgaard
; Simone, Giuseppe
; Rochester, Mark
; Green, Euan
; Fernandez-Pello, Sergio
; Blick, Christopher
; Porpiglia, Francesco
; Ingels, Alexandre
; Bratulic, Sinisa
; Antonelli, Alessandro
; Hakimi, A Ari
; Jewett, Michael A S
LU
; Ljungberg, Börje
; Bhindi, Bimal
; Marconi, Lorenzo
; Laird, Alexander
; Stewart, Grant D
; Nair, Rajesh
; Lund, Lars
; Barber, Neil
; Master, Viraj A
; Minervini, Andrea
; Karam, Jose A
; Gatto, Francesco
LU
and Bex, Axel
(Less) - organization
- publishing date
- 2025-08-20
- type
- Contribution to journal
- publication status
- epub
- subject
- in
- European Urology Oncology
- publisher
- Elsevier
- external identifiers
-
- pmid:40866172
- ISSN
- 2588-9311
- DOI
- 10.1016/j.euo.2025.07.011
- language
- English
- LU publication?
- yes
- additional info
- Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.
- id
- 1972a6fd-1e6c-4f99-be5e-60ac96e7d68b
- date added to LUP
- 2025-08-29 15:01:59
- date last changed
- 2025-08-29 15:10:49
@article{1972a6fd-1e6c-4f99-be5e-60ac96e7d68b,
abstract = {{<p>BACKGROUND AND OBJECTIVE: Nonmetastatic (M0) clear cell renal cell carcinoma (ccRCC) recurs in ∼20% of patients within 5 yr after surgery. With no biomarkers available, recurrence detection relies on radiological imaging. Urine glycosaminoglycan profiles (GAGomes) were previously associated with M0 ccRCC recurrence. We conducted an observational prospective multicentre diagnostic test cohort study to evaluate GAGomes for postsurgery recurrence detection in M0 ccRCC.</p><p>METHODS: Postsurgical M0 ccRCC patients with a Leibovich score of ≥5 points were included. Follow-up imaging up to 18 mo assessed radiological recurrence (reference standard). Urine GAGomes were measured every 3 mo to compute a GAGome score (index test). Sensitivity and specificity to radiological recurrence were calculated. The lead time between the first positive GAGome score and radiological recurrence was estimated. Bayesian joint modelling estimated recurrence-free survival hazard ratio (HR).</p><p>KEY FINDINGS AND LIMITATIONS: Of the 393 patients screened (January 2020 to November 2021), 134 met the inclusion criteria. The median follow-up was 16 mo (interquartile range [IQR]: 12-18) for those without recurrence. At the last follow-up visit, 16% had recurred. The GAGome score had 90% sensitivity (95% confidence interval [CI]: 62-100%) and 51% specificity (95% CI: 30-71%) to radiological recurrence. The positive and negative predictive values were 26% (95%CI: 4-46%) and 97% (95% CI: 87-100%), respectively. The median lead time was 4.2 mo (IQR: 1.6-6.4). A 10-point GAGome score increase was associated with an HR of 1.62 (95% high density interval: 1.11-2.30) for recurrence. The main limitation was short follow-up time.</p><p>CONCLUSIONS AND CLINICAL IMPLICATIONS: GAGome score had very high sensitivity to ccRCC recurrence, resulting in a negative predictive value of 97%. External validation foreseen in the study design aims to confirm its utility to personalise follow-up for M0 ccRCC patients.</p>}},
author = {{Dabestani, Saeed and Azawi, Nessn H and Campi, Riccardo and Järvinen, Petrus and Nisen, Harry and Capitanio, Umberto and Nielsen, Tommy Kjærgaard and Simone, Giuseppe and Rochester, Mark and Green, Euan and Fernandez-Pello, Sergio and Blick, Christopher and Porpiglia, Francesco and Ingels, Alexandre and Bratulic, Sinisa and Antonelli, Alessandro and Hakimi, A Ari and Jewett, Michael A S and Ljungberg, Börje and Bhindi, Bimal and Marconi, Lorenzo and Laird, Alexander and Stewart, Grant D and Nair, Rajesh and Lund, Lars and Barber, Neil and Master, Viraj A and Minervini, Andrea and Karam, Jose A and Gatto, Francesco and Bex, Axel}},
issn = {{2588-9311}},
language = {{eng}},
month = {{08}},
publisher = {{Elsevier}},
series = {{European Urology Oncology}},
title = {{Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate- and High-risk Nonmetastatic Clear Cell Renal Cell Carcinoma-An Observational Prospective Multicentre Diagnostic Test Cohort Study}},
url = {{http://dx.doi.org/10.1016/j.euo.2025.07.011}},
doi = {{10.1016/j.euo.2025.07.011}},
year = {{2025}},
}