Laura Iisager, Johanne Ahrenfeldt, Anna Krarup Keller, Tommy Kjærgaard Nielsen, Niels Fristrup, Iben Lyskjær
{"title":"KIDNEY-PAGER: analysis of circulating tumor DNA as a biomarker in renal cancer - an observational trial. Study protocol.","authors":"Laura Iisager, Johanne Ahrenfeldt, Anna Krarup Keller, Tommy Kjærgaard Nielsen, Niels Fristrup, Iben Lyskjær","doi":"10.2340/1651-226X.2024.25581","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Purpose: </strong>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.</p><p><strong>Material and methods: </strong>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.</p><p><strong>Interpretation: </strong>Results will pave the way for future ctDNA-guided clinical trials aiming to improve RCC management.</p>","PeriodicalId":7110,"journal":{"name":"Acta Oncologica","volume":"63 ","pages":"51-55"},"PeriodicalIF":2.7000,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11332532/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta Oncologica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2340/1651-226X.2024.25581","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
Acta Oncologica is a journal for the clinical oncologist and accepts articles within all fields of clinical cancer research. Articles on tumour pathology, experimental oncology, radiobiology, cancer epidemiology and medical radio physics are also welcome, especially if they have a clinical aim or interest. Scientific articles on cancer nursing and psychological or social aspects of cancer are also welcomed. Extensive material may be published as Supplements, for which special conditions apply.
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