Clinical trial · Observational
Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma
Sensitivity and Specificity of Glycosaminoglycan Scores in the Diagnosis of Early Progression in Advanced 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, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.
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 to progressive disease at response evaluation
- timeFrame
- 6 weeks and every 3 months after treatment start up to 12 months
- description
- ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks and every 3 months to progressive disease as assessed by radiological imaging during the scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure.
Secondary outcomes (1)
- measure
- Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in early prediction of objective response at first response evaluation
- timeFrame
- Baseline; 6 weeks after treatment start
- description
- ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks to complete response or partial response as assessed by radiological imaging during the first scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Diagnosis of renal cell carcinoma * Metastatic disease * Predicted life expectancy over 2 months * Patient referred for first line drug therapy * Standard imaging evaluation 12 weeks prior to inclusion * Planned for standard imaging within 16 weeks after start of therapy * Informed consent Exclusion Criteria: * Lack of proper compliance to accept continuous samplings
References
Publications (1)
- RESULTGatto F, Bratulic S, Jonasch E, Limeta A, Maccari F, Galeotti F, Volpi N, Lundstam S, Nielsen J, Stierner U. Plasma and Urine Free Glycosaminoglycans as Monitoring and Predictive Biomarkers in Metastatic Renal Cell Carcinoma: A Prospective Cohort Study. JCO Precis Oncol. 2023 Feb;7:e2200361. doi: 10.1200/PO.22.00361. PMID 36848607