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

Sponsor

Chalmers University of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03471897

Collaborator

Memorial Sloan Kettering Cancer Center (Other)

237

Enrollment

20.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Diagnostic Test: Glycosaminoglycan plasma score

Study Design

Study Type:

Observational

Actual Enrollment :

237 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 28, 2016

Actual Primary Completion Date :

Oct 25, 2017

Actual Study Completion Date :

Jan 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
RCC Patients with pathologically confirmed diagnosis of RCC	Diagnostic Test: Glycosaminoglycan plasma score 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.
Controls Subjects self-reported as healthy	Diagnostic Test: Glycosaminoglycan plasma score 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.

Arm

Intervention/Treatment

RCC

Patients with pathologically confirmed diagnosis of RCC

Diagnostic Test: Glycosaminoglycan plasma score

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.

Controls

Subjects self-reported as healthy

Diagnostic Test: Glycosaminoglycan plasma score

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.

Outcome Measures

Primary Outcome Measures

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

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 [1 month]
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.
Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC. [1 month]
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.
Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC [1 month]
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.
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC [53 months]
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.
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for metastatic recurrence-free survival in RCC [53 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.