Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732652
• Other study ID #: GAG-RCC-01
• Status: Completed
• Start date: June 2016
• Est. completion date: September 2021

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Chalmers University of Technology	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Gatto 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 Ope — 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 in the prediction of renal cell carcinoma recurrence after surgery	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.	Every 6 or 12 months after surgery up to 5 years
Secondary	Recurrence-free survival (RFS)	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.	Before surgery

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