Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma

Study Overview
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Brief Summary
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In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective consecutive series of patients with a radiographic finding of renal mass referred to primary surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs in healthy volunteers. The primary endpoints were the specificity and sensitivity of plasma GAGs in the detection of early stage RCC in pre-surgical samples versus healthy individuals. The investigators further analyzed how plasma GAGs varied according to stage, grade, RCC histology, other renal masses, and after surgery. Finally, the investigators estimated whether plasma GAGs could be used for prediction and surveillance of RCC recurrence.

Official Title
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Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: Glycosaminoglycan plasma score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with radiographic finding of renal mass referred to primary surgery; Healthy volunteers without any history of malignancy. Exclusion Criteria: No records on date of surgery; A pre-operative sample was obtained 50 days or earlier with respect to the date of surgery; - Absence of pre-operative samples following filtering out outliers or laboratory assay failures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RCC<br>Patients with pathologically confirmed diagnosis of RCC | Diagnostic Test: Glycosaminoglycan plasma score<br>* A score was calculated using a formula that factors in measurements of plasma glycosaminoglycan. A score higher than a here-determined threshold is deemed diagnostic of RCC.<br>|
| Controls<br>Subjects self-reported as healthy | Diagnostic Test: Glycosaminoglycan plasma score<br>* A score was calculated using a formula that factors in measurements of plasma glycosaminoglycan. A score higher than a here-determined threshold is deemed diagnostic of RCC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm |  | 1 month | 
| Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC | The shift is the absolute difference plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status. | 1 month | 
| Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC. | The shift is the absolute difference plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status. | 1 month | 
| Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC | The shift is the absolute difference plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status. | 1 month | 
| Hazard ratio of plasma GAG score dichotomized in Low vs. High score in pre-surgical samples for overall survival in RCC | The dichotomized plasma GAG score is a categorical binary variable based on a post-hoc cut-off value for the plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status. | 53 months | 
| Hazard ratio of plasma GAG score dichotomized in Low vs. High score in pre-surgical samples for metastatic recurrence-free survival in RCC | The dichotomized plasma GAG score is a categorical binary variable based on a post-hoc cut-off value for the plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status. | 53 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycosaminoglycans, biomarkers, diagnostics, prognostic, liquid biopsy