Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:

Sensitivity and Specificity of Glycosaminoglycan Scores in the Diagnosis of Early Progression in Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732665
• Other study ID #: GAG-RCC-02
• Status: Completed
• Start date: June 2016
• Est. completion date: February 2021

Study information

• Verified date: April 2023
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (3)

Lead Sponsor	Collaborator
Jens Nielsen	Sahlgrenska University Hospital, Sweden, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Gatto 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. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores to progressive disease at response evaluation	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.	6 weeks and every 3 months after treatment start up to 12 months
Secondary	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	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.	Baseline; 6 weeks after treatment start