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

April 16, 2018 updated by: Chalmers University of Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pathologically confirmed diagnosis of RCC treated with surgical resection of the tumor

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals
Time Frame: 1 month
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
Time Frame: 1 month
1 month
Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC
Time Frame: 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.
1 month
Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC.
Time Frame: 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.
1 month
Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC
Time Frame: 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.
1 month
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC
Time Frame: 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.
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
Time Frame: 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.
53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chalmers University of Technology

Collaborators

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 28, 2016

Primary Completion (ACTUAL)

October 25, 2017

Study Completion (ACTUAL)

January 18, 2018

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAG-RCC-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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