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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-28

Study Completion Date

2018-01-18

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.

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Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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RCC

Patients with pathologically confirmed diagnosis of RCC

Glycosaminoglycan plasma score

Intervention Type DIAGNOSTIC_TEST

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

Glycosaminoglycan plasma score

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes