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The study aims to determine and compare total serum concentrations of copper, zinc, and iron, the proportions of free copper and copper bound to ceruloplasmin, and the 65Cu/63Cu isotopic ratio between healthy volunteers and BTC patients. Measurements are performed using inductively coupled plasma-mass spectrometry (ICP-MS), with computed tomography evaluation of systemic therapy response.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/determination-of-copper-and-other-trace-elements-in-serum-samples-from-patients-with-biliary-tract-cancers-study-protocol/330801/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/determination-of-copper-and-other-trace-elements-in-serum-samples-from-patients-with-biliary-tract-cancers-study-protocol/330801.png","ImageObject",300,407,{"name":92,"@type":93},"Violet","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-09","2026-09-21",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",18,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What is the main objective of the study protocol?","Question",{"text":113,"@type":114},"To determine and compare serum levels of copper, zinc, and iron, including free vs. ceruloplasmin-bound copper and the 65Cu/63Cu isotopic ratio in healthy volunteers and BTC patients.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"How will trace elements and copper isotopic fractionation be measured?",{"text":118,"@type":114},"Using inductively coupled plasma-mass spectrometry (ICP-MS)-based analytical methods for metal-based biomarker research in oncology.",{"name":120,"@type":111,"acceptedAnswer":121},"How will treatment response for biliary tract cancer be evaluated?",{"text":122,"@type":114},"Response to systemic therapy will be evaluated using computed tomography.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},330801,1790015981,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146,"preview_page_count":4},4398048950312,"https://ap-avatar.wpscdn.com/avatar/400002538284de19e3c?_k=1778320343897328908","[Radiology and Oncology | Ljubljana | Slovenia | www.radioloncol.com](Radiology and Oncology | Ljubljana | Slovenia | www.radioloncol.com)    \n300  \nstudy protocol  \nDetermination of copper and other trace elements in serum samples from patients with biliary tract cancers: prospective noninterventional nonrandomized clinical study protocol  \nMartina Rebersek1,2 , Nezka Hribernik1,2 , Katarina Markovic3 , Stefan Markovic3 , Katja Ursic Valentinuzzi4,5 , Maja Cemazar4,6 , Tea Zuliani3,7 , Radmila Milacic3,7 , Janez Scancar3,7  \n1 Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia  \n2 Medical Faculty, University of Ljubljana, Ljubljana, Slovenia  \n3 Jožef Stefan Institute, Ljubljana, Slovenia  \n4 Department of Experimental Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia  \n5 Biotechnical Faculty, University of Ljubljana, Ljubljana, Slovenia  \n6 Faculty of Health Sciences, University of Primorska, Izola, Slovenia  \n7 Jožef Stefan International Postgraduate School, Ljubljana, Slovenia  \nRadiol Oncol 2024; 58(2): 300-310.  \nReceived 18 February 2024 Accepted 9 March 2024  \nCorrespondence to: Assist. Prof. Martina Reberšek, M.D., Ph.D., Department of Medical Oncology, Institute of Oncology Ljubljana, Zaloška 2, SI-1000 Ljubljana, [Slovenia. E-mail: mrebersek@onko-i.si](Slovenia. E-mail: mrebersek@onko-i.si)  \n[Disclosure: No potential conflicts of interest were disclosed.](Disclosure: No potential conflicts of interest were disclosed.)  \nThis is an open access article distributed under the terms of the CC-BY license ([https://creativecommons.org/licenses/by/4.0/](https://creativecommons.org/licenses/by/4.0/)).  \nBackground. Biliary tract cancers (BTCs) are usually diagnosed at an advanced stage, when the disease is incurable. Currently used tumor biomarkers have limited diagnostic value for BTCs, so there is an urgent need for sensitive and specific biomarkers for their earlier diagnosis. Deregulation of the homeostasis of trace elements is involved in the carcinogenesis of different cancers, including BTCs. The objective of the study is to determine/compare the total concentrations of copper (Cu), zinc (Zn) and iron (Fe) and the proportions of free Cu and Cu bound to ceruloplasmin (Cp) and the isotopic ratio of 65Cu/63Cu in serum samples from healthy volunteers and cancer patients using inductively coupled plasma-mass spectrometry-based methods (ICP-MS) .  \nPatients and methods. In this prospective, noninterventional, nonrandomized study 20 patients and 20 healthy volunteers will be enrolled to identify serum Cu, Zn and Fe levels, Cu isotopic fractionation as a predictive biomarker of response to systemic therapy of BTCs, which will be evaluated by computed tomography. Newly developed analytical methods based on ICP-MS will be applied to metal-based biomarker research in oncology.  \nConclusions. In the study the comparison of the total concentration of selected trace elements, the proportion of free Cu and Cu bound to Cp and the isotopic ratio of 65Cu/63Cu in serum samples from healthy volunteers and cancer patients will be conducted to provide the foundation for the development of a BTC cancer screening methodology and the data on their usability as a potential predictive biomarker for BTCs of response to systemic therapy.  \nKey words: trace elements; copper; predictive biomarkers of response; biliary tract cancer; systemic treatment  \nIntroduction  \nBiliary tract cancers (BTCs) are a heterogeneous group of uncommon and rare epithelial tumors  \narising from biliary duct cells. Most of them areadenocarcinomas and represent \u003C 1% of all human cancers or 3% of gastrointestinal cancers.1,2 Based on anatomical location, BTCs are subdivided into  \nRadiol Oncol 2024; 58(2): 300-310. doi: 10.2478/raon-2024-0026  \nRebersek M et al. / Determination of copper and other trace elements in patients with biliary tract cancers  \n301  \nintrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcin","cbCaibXGeNZL0jJm","https://ap.wps.com/l/cbCaibXGeNZL0jJm","pdf",737664,11,"English","# Background\n## Objectives\n# Patients and methods\n## Analytical approach\n## Study evaluation\n# Conclusions\n# Key words","[{\"question\":\"What is the main objective of the study protocol?\",\"answer\":\"To determine and compare serum levels of copper, zinc, and iron, including free vs. ceruloplasmin-bound copper and the 65Cu/63Cu isotopic ratio in healthy volunteers and BTC patients.\"},{\"question\":\"How will trace elements and copper isotopic fractionation be measured?\",\"answer\":\"Using inductively coupled plasma-mass spectrometry (ICP-MS)-based analytical methods for metal-based biomarker research in oncology.\"},{\"question\":\"How will treatment response for biliary tract cancer be evaluated?\",\"answer\":\"Response to systemic therapy will be evaluated using computed tomography.\"}]","Determination of copper and other trace elements in serum samples from patients with biliary tract cancers - study protocol | PDF",1789990205,28]