Specificity and Sensitivity of Glycosaminoglycan Scores in the Early Diagnosis of Recurrent Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
Purpose: In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. For example to diagnose early recurrence after surgical treatment; to screen population at risk of RCC; or to distinguish benign masses from RCC before surgical treatment. To this end, plasma and urine GAGs will be measured in a prospective cohort of patients referred to surgical treatment for RCC. The resulting GAG scores are then correlated to post-surgical recurrence, to post-surgical definitive diagnosis and and to tumor size if RCC. In a subset cohort of patients at high risk of RCC recurrence, plasma and urine GAGs will be monitored to observe its correlation with disease recurrence.
Study Type: Observational
Clinical Trials Identifier NCT 8-digits: NCT02732652
Sponsor: Chalmers University of Technology
Primary Outcome Measures:
- Measure: Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in the prediction of renal cell carcinoma recurrence after surgery
- Time Frame: Before surgery and every 6 or 12 months after surgery up to 5 years
- Safety Issue:
- Measure: Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in the prediction of definitive pathological diagnosis of renal cell carcinoma after surgery
- Time Frame: Before surgery
- Safety Issue:
Secondary Outcome Measures:
- Measure: Recurrence-free survival (RFS)
- Time Frame: Before surgery and up to 5 years after surgery
- Safety Issue:
- Measure: Overall survival (OS)
- Time Frame: Before surgery and up to 5 years after surgery
- Safety Issue:
- Measure: Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in prediction of tumor size in cm
- Time Frame: Before surgery
- Safety Issue:
Estimated Enrollment: 60
Study Start Date: June 2016
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Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
Inclusion Criteria:
- Patients referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
- Predicted life expectancy over 2 months
- Standard imaging evaluation 12 weeks prior to inclusion
- Planned for standard imaging within 16 weeks after start of therapy
Exclusion Criteria:
- Lack of proper compliance to accept continuous samplings.
Contact:
- Francesco Gatto, PhD
- 0046317723140
Location:
- Sahlgrenska University Hospital
- Göteborg Sweden
View trial on ClinicalTrials.gov