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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471897
• Other study ID #: GAG-RCC-03
• Status: Completed
• First received: March 14, 2018
• Last updated: April 16, 2018
• Start date: April 28, 2016
• Est. completion date: January 18, 2018

Study information

• Verified date: April 2018
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: January 18, 2018
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chalmers University of Technology	Memorial Sloan Kettering Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals		1 month
Secondary	Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm		1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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