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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| University of Modena and Reggio Emilia | OTHER |
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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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| Measure | Description | Time Frame |
|---|---|---|
| Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores to progressive disease at response evaluation | ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks and every 3 months to progressive disease as assessed by radiological imaging during the scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure. | 6 weeks and every 3 months after treatment start up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in early prediction of objective response at first response evaluation | ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks to complete response or partial response as assessed by radiological imaging during the first scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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Untreated patients with diagnosis of metastatic renal cell carcinoma referred for first line treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Jens Nielsen, PhD | Chalmers University of Technology | Principal Investigator |
| Ulrika Stierner, M.D. PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36848607 | Result | Gatto F, Bratulic S, Jonasch E, Limeta A, Maccari F, Galeotti F, Volpi N, Lundstam S, Nielsen J, Stierner U. Plasma and Urine Free Glycosaminoglycans as Monitoring and Predictive Biomarkers in Metastatic Renal Cell Carcinoma: A Prospective Cohort Study. JCO Precis Oncol. 2023 Feb;7:e2200361. doi: 10.1200/PO.22.00361. |
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Data will be accessible upon study publication
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Ethylenediaminetetraacetic acid (EDTA)-plasma from blood obtained through venipuncture; and any-void urine.
| Baseline; 6 weeks after treatment start |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |