Clinical trial · Observational
Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma
Specificity and Sensitivity of Glycosaminoglycan Scores in the Early Diagnosis of Recurrent Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. For example to diagnose early recurrence after surgical treatment; to screen population at risk of RCC; or to distinguish benign masses from RCC before surgical treatment. To this end, plasma and urine GAGs will be measured in a prospective cohort of patients referred to surgical treatment for RCC. The resulting GAG scores are then correlated to post-surgical recurrence, to post-surgical definitive diagnosis and and to tumor size if RCC. In a subset cohort of patients at high risk of RCC recurrence, plasma and urine GAGs will be monitored to observe its correlation with disease recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in the prediction of renal cell carcinoma recurrence after surgery
- timeFrame
- Every 6 or 12 months after surgery up to 5 years
- description
- Radiological assessment of patients with definitive diagnosis of RCC and classified as high risk will be carried out as standard-of-care during follow-up and subjected to correlative analysis relative to the plasma/urine glycosaminoglycan scores (or their change) as assessed by longitudinal sampling.
Secondary outcomes (1)
- measure
- Recurrence-free survival (RFS)
- timeFrame
- Before surgery
- description
- Survival analysis will be performed by Kaplan Meier and significance analysis will use the log-rank test. Cox multivariate analysis will be performed to look at the number and molecular characteristics of the glycosaminoglycan scores as independent prognostic parameters of survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients referred for partial or radical nephrectomy for suspicion of renal cell carcinoma * Predicted life expectancy over 2 months * Standard imaging evaluation 12 weeks prior to inclusion * Planned for standard imaging within 16 weeks after start of therapy Exclusion Criteria: * Lack of proper compliance to accept continuous samplings.
References
Publications (1)
- RESULTGatto F, Dabestani S, Bratulic S, Limeta A, Maccari F, Galeotti F, Volpi N, Stierner U, Nielsen J, Lundstam S. Plasma and Urine Free Glycosaminoglycans as Monitoring Biomarkers in Nonmetastatic Renal Cell Carcinoma-A Prospective Cohort Study. Eur Urol Open Sci. 2022 Jun 29;42:30-39. doi: 10.1016/j.euros.2022.06.003. eCollection 2022 Aug. PMID 35911082