Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma

Completed

• Conditions: Carcinoma, Renal Cell

• Registration Number: NCT02732665
• Lead Sponsor: Jens Nielsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-11
• Study Start: 2016-06
• Primary Completion: 2020-12
• Study Completion: 2021-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores to progressive disease at response evaluation	6 weeks and every 3 months after treatment start up to 12 months	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 Outcome Measures

Name	Time	Method
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	Baseline; 6 weeks after treatment start	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.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden