Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced 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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-02-28

Brief Summary

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In this study, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.

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Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Diagnosis of renal cell carcinoma
* Metastatic disease
* Predicted life expectancy over 2 months
* Patient referred for first line drug therapy
* Standard imaging evaluation 12 weeks prior to inclusion
* Planned for standard imaging within 16 weeks after start of therapy
* Informed consent