[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-340377-105":59,"doc-detail-340377-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","clinical-validation-of-a-cell-free-dna-fragmentome-assay-for-augmentation-of-lung-cancer-early-detection","Clinical Validation of a Cell-Free DNA Fragmentome Assay for Augmentation of Lung Cancer Early Detection","","A prospective case-control study developed and validated a blood-based lung cancer detection test using genome-wide cell-free DNA fragmentation profiles. Among 958 lung cancer screening-eligible individuals, fragmentome features reflected genomic and chromatin characteristics of lung cancer, and machine learning identified individuals at higher or lower risk. The classifier was trained on 576 cases and controls, then validated on 382 held-out samples, showing high sensitivity and consistency across demographic groups and comorbidities. Modeling suggested potential prevention of thousands of lung cancer deaths.",{"@graph":69,"@context":122},[70,84,105],{"@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":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/clinical-validation-of-a-cell-free-dna-fragmentome-assay-for-augmentation-of-lung-cancer-early-detection/340377/",{"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/clinical-validation-of-a-cell-free-dna-fragmentome-assay-for-augmentation-of-lung-cancer-early-detection/340377.png","ImageObject",300,407,{"name":92,"@type":93},"Eden","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-23","2026-09-22",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the main goal of the study on the cell-free DNA fragmentome assay?","Question",{"text":112,"@type":113},"To develop and validate a blood-based lung cancer detection test that can be followed by low-dose CT when positive.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How were machine-learning models trained and validated?",{"text":117,"@type":113},"The classifier was trained using 576 cases and controls and validated in a held-out group of 382 cases and controls.",{"name":119,"@type":110,"acceptedAnswer":120},"What did the validation results show?",{"text":121,"@type":113},"The validation demonstrated high sensitivity for lung cancer and consistency across demographic groups and comorbid conditions.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},340377,1790823916,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":56,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},1374391974468,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","ReseaRch aRticle  \nClinical Validation of a Cell-Free DNA Fragmentome Assay for Augmentation of Lung Cancer Early Detection   \nPeter J. Mazzone1, Peter B. Bach2, Jacob Carey2, Caitlin A. Schonewolf2, Katalin Bognar3, Manmeet S. Ahluwalia4, Marcia Cruz-Correa5, David Gierada6, Sonali Kotagiri2, Kathryn Lloyd7, Fabien Maldonado8, Jesse D. Ortendahl9, Lecia V. Sequist10, Gerard A. Silvestri11, Nichole Tanner12, Jeffrey C. Thompson13, Anil Vachani13,  \nKwok-Kin Wong14, Ali H. Zaidi15, Joseph Catallini2, Ariel Gershman2, Keith Lumbard2, Laurel K. Millberg2, Jeff Nawrocki2, Carter Portwood2, Aakanksha Rangnekar2, Carolina Campos Sheridan2, Niti Trivedi2, Tony Wu2, Yuhua Zong2, Lindsey Cotton2, Allison Ryan2, Christopher Cisar2, Alessandro Leal2, Nicholas Dracopoli2,  \nRobert B. Scharpf16, Victor E. Velculescu16, and Luke R. G. Pike17  \nLung cancer screening via annual low-dose computed tomography has poor adop  \ntion. We conducted a prospective case–control study among 958 individuals eligible for lung cancer screening to develop a blood-based lung cancer detection test that when positive is followed by a low-dose computed tomography. Changes in genome-wide cell-free DNA fragmentation profiles (fragmentomes) in peripheral blood reflected genomic and chromatin characteristics of lung cancer. We applied machine learning to fragmentome features to identify individuals who were more or less likely to have lung cancer. We trained the classifier using 576 cases and controls from study samples and validated it in a held-out group of 382 cases and controls. The validation demonstrated high sensitivity for lung cancer and consistency across demographic groups and comorbid conditions. Applying test performance to the screening eligible population ina 5-year model with modest utilization assumptions suggested the potential to prevent thousands of lung cancer deaths.  \nSigNiFiCANCE: Lung cancer screening has poor adoption. Our study describes the development and validation of a novel blood-based lung cancer screening test utilizing a highly affordable, low-coverage genome-wide sequencing platform to analyze cell-free DNA fragmentation patterns. The test could improve lung cancer screening rates leading to substantial public health benefits.  \nSee related commentary by Haber and Skates, p. 2025  \nintRoduction  \nLung cancer is the number one cancer killer of men and women in the United States, accounting for more than 125,000 deaths per year in the US and nearly 1.8 million deaths per year globally (1–3). Annual screening for lung cancer among high-risk individuals is highly effective at detecting early-stage cancer. Two randomized controlled trials of chest low-dose computed tomography (LDCT) conducted in well-defined, high-risk populations, demonstrated lung cancer mortality reductions of 20% to 24%(4–6) . These data led  \n1Cleveland Clinic, Cleveland, Ohio. 2DELFI Diagnostics, Baltimore, Maryland.  \n3Medicus Economics, LLC, Formerly PHAR, San Francisco, California.  \n4Miami Cancer Institute, Baptist Health South Florida, Miami, Florida.  \n5Pan American Center for Oncology, San Juan, Puerto Rico. 6Washington University at St. Louis, St. Louis, Missouri. 7Centura Health, Aurora, Colorado. 8Vanderbilt Health, Nashville, Tennessee. 9Stratevi, Formerly PHAR, San Francisco, California. 10Massachusetts General Hospital, Boston, Massachusetts. 11Medical University of South Carolina, Charleston, South Carolina. 12Department of Veterans Affairs, Charleston, South Carolina.  \n13Division of Pulmonary, Allergy and Critical Care Medicine, Thoracic Oncology Group, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 14New York University Langone Health, New York, New York. 15Allegheny Health Network, Pittsburgh, Pennsylvania. 16Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.  \n17Memorial Sloan Kettering Cancer Center, New York, New York. Corre","cbCainT9sUSGnG3Y","https://ap.wps.com/l/cbCainT9sUSGnG3Y","pdf",9603486,"English","# Introduction\n## Lung cancer screening outcomes and adoption gaps\n## Barriers to LDCT screening\n# Significance\n## Potential public health benefits","[{\"question\":\"What was the main goal of the study on the cell-free DNA fragmentome assay?\",\"answer\":\"To develop and validate a blood-based lung cancer detection test that can be followed by low-dose CT when positive.\"},{\"question\":\"How were machine-learning models trained and validated?\",\"answer\":\"The classifier was trained using 576 cases and controls and validated in a held-out group of 382 cases and controls.\"},{\"question\":\"What did the validation results show?\",\"answer\":\"The validation demonstrated high sensitivity for lung cancer and consistency across demographic groups and comorbid conditions.\"}]","Clinical Validation of a Cell-Free DNA Fragmentome Assay for Augmentation of Lung Cancer Early Detection | PDF",1790036167,48]