Clinical trial NCT03471897: Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma
Official title: Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: glycosaminoglycans
biomarkers
diagnostics
prognostic
liquid biopsy
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2018-03-21
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically confirmed diagnosis of RCC treated with surgical resection of the tumor

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals
timeFrame: 1 month
Secondary outcomes:
measure: Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm
timeFrame: 1 month
measure: Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC
timeFrame: 1 month
measure: Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC.
timeFrame: 1 month
measure: Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC
timeFrame: 1 month
measure: Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC
timeFrame: 53 months
measure: Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for metastatic recurrence-free survival in RCC
timeFrame: 53 months
Other outcomes:
Locations:
Study officials:
References:
citation: Gatto F, Blum KA, Hosseini SS, Ghanaat M, Kashan M, Maccari F, Galeotti F, Hsieh JJ, Volpi N, Hakimi AA, Nielsen J. Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma. Eur Urol Oncol. 2018 Oct;1(5):364-377. doi: 10.1016/j.euo.2018.04.015. Epub 2018 Jun 13.