KIDNEY-PAGER: analysis of circulating tumor DNA as a biomarker in renal cancer – an observational trial. Study protocol

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DOI:

https://doi.org/10.2340/1651-226X.2024.25581

Keywords:

Renal cell carcinoma, translational research, biomarkers, circulating tumor DNA, risk stratification, minimal residual disease, liquid biopsy

Abstract

Background: Management of localized renal cell carcinoma (RCC) is challenged by inaccurate methods to assess the risk of recurrence and deferred detection of relapse and residual disease after radical or partial nephrectomy. Circulating tumor DNA (ctDNA) has been proposed as a potential biomarker in RCC.

Purpose: Conduction of an observational study to evaluate the validity of ctDNA as a biomarker of the risk of recurrence and subclinical residual disease to improve postoperative surveillance.

Material and methods: Urine and blood will be prospectively collected before and after surgery of the primary tumor from up to 500 patients until 5 years of follow-up. ctDNA analysis will be performed using shallow whole genome sequencing and cell-free methylated DNA immunoprecipitation sequencing. ctDNA levels in plasma and urine will be correlated to oncological outcomes. Residual blood and urine as well as tissue biopsies will be biobanked for future research.

Interpretation: Results will pave the way for future ctDNA-guided clinical trials aiming to improve RCC management.

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References

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Published

2024-02-23

How to Cite

Iisager, L., Ahrenfeldt, J. ., Keller, A. K., Nielsen, T. K., Fristrup, N., & Lyskjær , I. (2024). KIDNEY-PAGER: analysis of circulating tumor DNA as a biomarker in renal cancer – an observational trial. Study protocol. Acta Oncologica, 63(1), 51–55. https://doi.org/10.2340/1651-226X.2024.25581

Issue

Vol. 63 (2024): Acta Oncologica

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Short report

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Copyright (c) 2024 Laura Iisager, Johanne Ahrenfeldt, Anna Krarup Keller, Tommy Kjærgaard Nielsen, Niels Fristrup, Iben Lyskjær

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This work is licensed under a Creative Commons Attribution 4.0 International License.

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