oncotomskСибирский онкологический журналSiberian journal of oncology1814-48612312-3168Tomsk National Research Medical Сепtеr of the Russian Academy of Sciences10.21294/1814-4861-2025-24-6-108-126oncotomsk-3956Research ArticleОБЗОРЫREVIEWSИнновационные геномные технологии неинвазивного скрининга злокачественных новообразованийInnovative genomic technologies for non-invasive cancer screeninghttps://orcid.org/0000-0003-4775-3299ЛюбченкоЛ. Н.LyubchenkoL. N.

Любченко Людмила Николаевна - доктор медицинских наук, профессор, заведующая отделом молекулярной генетики и клеточных технологий, НИИУИР им. Н.В. Лопаткина – филиал ФГБУ «НМИЦР» Минздрава России; ФГБУ «НИИУИР» Минздрава России.

249036, Обнинск, ул. Королева, 4; 105425, Москва, 3-я Парковая ул., 51

Lyudmila N. Lyubchenko - MD, DSc, Professor, Head of the Department of Molecular Genetics and Cell Technologies, N.A. Lopatkin Institute of Urology and Interventional Radiology – branch of the NMRRC, MHR; National Medical Research Radiological Centre, MHR.

4, Koroleva St., Obninsk, 249036; 51, 3rd Parkovaya St., building 4, Moscow, 105425

https://orcid.org/0000-0001-8291-804XЧернавинаК. М.ChernavinaK. M.

Чернавина Карина Максимовна - научный сотрудник отдела молекулярной генетики и клеточных технологий, Научно-исследовательский институт урологии и интервенционной радиологии им. Н.В. Лопаткина – филиал ФГБУ «НИИУИР» Минздрава России.

105425, Москва, 3-я Парковая ул., 51

Karina M. Chernavina - MD, Researcher, Department of Molecular Genetics and Cell Technologies, N.A. Lopatkin Institute of Urology and Interventional Radiology – branch of the NMRRC, MHR.

51, 3rd Parkovaya St., building 4, Moscow, 105425

КапринИ. А.KaprinI. A.

Каприн Иван Андреевич - кандидат медицинских наук, главный врач, ГБУЗ Московской области «Одинцовская областная больница»; доцент кафедры Высшей школы управления здравоохранением, Институт лидерства и управления здравоохранением, Первый МГМУ им. И.М. Сеченова.

143003, Одинцово, ул. Маршала Бирюзова, 5; 119991, Москва, ул. Трубецкая, 8, стр. 2

Ivan A. Kaprin - MD, PhD, Chief Medical Officer, Odintsovo Regional Hospital (Odintsovo, Russia); Associate Professor, Department of the Higher School of Healthcare Management, Institute of Leadership and Healthcare Management, I.M. Sechenov FMSMU.

5, Marshal Biryuzov St., Odintsovo, 143003; 8/2, Trubetskaya St., Moscow, 119991

https://orcid.org/0000-0002-5676-4224МошуровР. И.MoshurovR. I.

Мошуров Руслан Иванович - кандидат медицинских наук, старший научный сотрудник отделения абдоминальной хирургии, заведующий отделом панкреатобилиарной хирургии, Московский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «НМИЦР» Минздрава России; ассистент кафедры онкологии, Российский университет дружбы народов.

125284, г. Москва, 2-й Боткинский пр-д, 3; 117198, Москва, ул. Миклухо-Маклая, 6

Ruslan I. Moshurov - MD, PhD, Senior Researcher, Department of Abdominal Surgery, Head of the Department of Pancreatobiliary Surgery, P.A. Hertsen Moscow Oncology Research Institute – branch of NMRRC, MHR; Assistant, Department of Oncology, RUDNU.

3, 2nd Botkinsky proezd, Moscow, 125284; 6, Miklukho-Maklaya St., Moscow, 117198

https://orcid.org/0000-0003-1879-6978ТрифановВ. С.TrifanovV. S.

Трифанов Владимир Сергеевич - доктор медицинских наук, доцент, заведующий центром абдоминальной хирургии, Московский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «НИИУИР» Минздрава России.

125284, г. Москва, 2-й Боткинский пр-д, 3

Vladimir S. Trifanov - MD, DSc, Associate Professor, Head of the Center for Abdominal Surgery, P.A. Hertsen Moscow Oncology Research Institute – branch of NMRRC, MHR.

3, 2nd Botkinsky proezd, Moscow, 125284

БоробоваВ. С.BorobovaV. S.

Боробова Виктория Сергеевна – аспирант.

630090, Новосибирск, ул. Пирогова, 2

Viktoriya S. Borobova – Postgraduate.

2, Timakova St., Novosibirsk, 630090

https://orcid.org/0000-0002-6903-4239КоваленкоC. П.KovalenkoS. P.

Коваленко Сергей Петрович - доктор биологических наук, доцент кафедры клинической биохимии, ФГАОУ ВО «Новосибирский национальный исследовательский государственный университет»; заместитель директора по науке, ООО «Биолинк».

630090, Новосибирск, ул. Пирогова, 2; 630090, Новосибирск, ул. Николаева, 13

Sergei P. Kovalenko - DSc, Associate Professor, Department of Clinical Biochemistry, Novosibirsk SU; Deputy Director for Science, Biolink Ltd.

2, Timakova St., Novosibirsk, 630090; 13, Nikolaeva St., Novosibirsk, 630090

https://orcid.org/0000-0003-4578-0146Фэй (亓飞)ЦиFei (亓飞)Qi

Фэй Ци (亓飞) - доцент Государственной лаборатории биологии клеточного стресса, факультет естественных наук.

361102, Сямэнь

Fei Qi (亓飞) - Assistant Professor, State Key Laboratory of Cellular Stress Biology, School of Life Sciences.

Xiamen, 361102

https://orcid.org/0009-0001-4990-7346Лу (唐露)ТанLu (唐露)Tang

Лу Тан (唐露) - постдокторант Государственной лаборатории биологии клеточного стресса, факультет естественных наук.

361102, Сямэнь

Lu Tang (唐露) - Postdoctoral fellow, State Key Laboratory of Cellular Stress Biology, School of Life Sciences.

Xiamen, 361102

https://orcid.org/0009-0005-6466-5348ЖароваЕ. П.ZharovaE. P.

Жарова Елена Петровна - кандидат биологических наук, научный сотрудник.

249036, Обнинск, ул. Королева, 4

Elena P. Zharova - PhD, Researcher.

4, Koroleva St., Obninsk, 249036

https://orcid.org/0000-0003-2647-4856КапрановФ.KapranovP.

Капранов Филипп - PhD, профессор Государственной лаборатории биологии клеточного стресса, факультет естественных наук.

361102, Сямэнь

Philipp Kapranov - PhD, Professor, State Key Laboratory of Cellular Stress Biology, School of Life Sciences.

Xiamen, 361102

https://orcid.org/0000-0001-8784-8415КапринА. Д.KaprinA. D.

Каприн Андрей Дмитриевич - доктор медицинских наук, профессор, академик РАН и РАО, заведующий кафедрой онкологии и рентгенорадиологии им. В.П. Харченко, ФГАОУ ВО «РУДН»; директор, Московский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России; генеральный директор, ФГБУ «НМИЦР» Минздрава России.

SPIN-код: 1759-8101.

Researcher ID (WOS): K-1445-2014.

249036, Обнинск, ул. Королева, 4; 125284, г. Москва, 2-й Боткинский пр-д, 3; 117198, Москва, ул. Миклухо-Маклая, 6

Andrei D. Kaprin - MD, DSc, Professor, Academician of the Russian Academy of Sciences, Head of Chair of Oncology and Radiology named after Kharchenko, RUDN University; Director, P.A. Hertsen Moscow Oncology Research Institute – branch of the NMRRC, MHR; Director General, NMRRC of the MHR.

Researcher ID (WOS): K-1445-2014.

4, Koroleva St., Obninsk, 249036; 3, 2nd Botkinsky proezd, Moscow, 125284; 6, Miklukho-Maklaya St., Moscow, 117198

ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России; Научно-исследовательский институт урологии и интервенционной радиологии им. Н.В. Лопаткина – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава РоссииРоссияNational Medical Research Radiological Centre, Ministry of Health of Russia; N.A. Lopatkin Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiological Centre, Ministry of Health of RussiaRussian FederationНаучно-исследовательский институт урологии и интервенционной радиологии им. Н.В. Лопаткина – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава РоссииРоссияN.A. Lopatkin Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiological Centre, Ministry of Health of RussiaRussian FederationГБУЗ Московской области «Одинцовская областная больница»; Первый Московский государственный медицинский университет им. И.М. СеченоваРоссияOdintsovo Regional Hospital; I.M. Sechenov First Moscow State Medical UniversityRussian FederationМосковский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава Росси; Российский университет дружбы народовРоссияP.A. Hertsen Moscow Oncology Research Institute – branch of National Medical Radiology Research Center, Ministry of Health of Russia; RUDN UniversityRussian FederationМосковский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава РоссиРоссияP.A. Hertsen Moscow Oncology Research Institute – branch of National Medical Radiology Research Center, Ministry of Health of RussiaRussian FederationФГАОУ ВО «Новосибирский национальный исследовательский государственный университет»РоссияNovosibirsk State UniversityRussian FederationФГАОУ ВО «Новосибирский национальный исследовательский государственный университет»; ООО «Биолинк»РоссияNovosibirsk State University; Biolink LtdRussian FederationСямэньский университетКитайXiamen UniversityChinaФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава РоссииРоссияNational Medical Research Radiological Centre, Ministry of Health of RussiaRussian FederationФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России; Московский научно-исследовательский онкологический институт им. П.А. Герцена – филиал ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России; Российский университет дружбы народовРоссияNational Medical Research Radiological Centre, Ministry of Health of Russia; P.A. Hertsen Moscow Oncology Research Institute – branch of National Medical Radiology Research Center, Ministry of Health of Russia; RUDN UniversityRussian Federation202513012026246108126Copyright © Любченко Л.Н., Чернавина К.М., Каприн И.А., Мошуров Р.И., Трифанов В.С., Боробова В.С., Коваленко C.П., Фэй (亓飞) Ц., Лу (唐露) Т., Жарова Е.П., Капранов Ф., Каприн А.Д., 20262026Любченко Л.Н., Чернавина К.М., Каприн И.А., Мошуров Р.И., Трифанов В.С., Боробова В.С., Коваленко C.П., Фэй (亓飞) Ц., Лу (唐露) Т., Жарова Е.П., Капранов Ф., Каприн А.Д.Lyubchenko L.N., Chernavina K.M., Kaprin I.A., Moshurov R.I., Trifanov V.S., Borobova V.S., Kovalenko S.P., Fei (亓飞) Q., Lu (唐露) T., Zharova E.P., Kapranov P., Kaprin A.D.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.siboncoj.ru/jour/article/view/3956

Злокачественные новообразования (ЗНО) являются одной из основных причин смертности, на борьбу с которой нацелены приоритетные программы и стратегии научно-технологического развития в области общественного здравоохранения и здоровьесбережения. Современные технологии скрининга ориентированы на раннюю диагностику ЗНО с целью улучшения отдаленных результатов лечения, однако большинство из них характеризуется инвазивностью и низкой комплаентностью пациентов. В связи с этим неинвазивная диагностика ЗНО различных локализаций рассматривается как перспективное направление в молекулярной биологии и онкологии. Благодаря достижениям в области молекулярной генетики и биоинформатики идентифицирован широкий спектр диагностических, прогностических и предиктивных биомаркеров, анализ которых возможен не только в образцах опухолевой ткани, но и в периферической крови.

Цель исследования – анализ и обобщение современных научнопрактических данных в области скрининговой неинвазивной диагностики ЗНО различных локализаций методом молекулярно-биологического анализа c оценкой этапов разработки, вопросов правового регулирования и интеграции в страховые медико-социальные программы инновационных тест-систем и диагностикумов.

Материал и методы

Материал и методы. Материалом для исследования послужили отечественные и зарубежные базы научных данных, в частности National Library of Medicine, PubMed, Elibrary, Google Scholar, а также открытые интернет-ресурсы. Поиск осуществлялся по ключевым словам: сancer; malignant neoplasm; tumor; diagnostic; non-invasive; early; blood; Blood-based tests; test system; screening; pancancer; multi-cancer; sequencing; PCR; marker; DNA; cfDNA; multi-cancer early detection; MCED. Аналитический обзор включал отчеты о клинических исследованиях, метаанализы, систематические обзоры, когортные рандомизированные исследования за период с 2008 по 2025 г.

Результаты

Результаты. Продемонстрирована тенденция широкомасштабного внедрения в клиническую практику универсальной неинвазивной технологии детекции ЗНО, в том числе на ранних стадиях неопластического процесса. Ретро/проспективные мультицентровые исследования и метаанализы, выполненные за последние 15 лет, представили достижения междисциплинарного мультимодального анализа клинических, геномных, транскриптомных, эпигеномных и других данных при оценке разнородных категорий пациентов, сделав акцент на экономическую эффективность разработанных методик.

Заключение

Заключение. Остается актуальным проведение крупных популяционно-ориентированных исследований с учетом расовой и этнической принадлежности, позволяющих валидировать методологические подходы и оценить эффективность масштабной интеграции неинвазивной скрининговой технологии диагностики в онкологическую клиническую практику, в том числе и для многонационального населения Российской Федерации.

Cancer is a leading cause of mortality worldwide and the focus of priority programs and strategies for scientific and technological development in public health and health promotion. Modern screening technologies are aimed at early cancer diagnosis to improve treatment outcomes; however most of them are characterized by invasiveness and low patient compliance. Therefore, non-invasive cancer diagnosis is a promising field in molecular biology and oncology. Advances in molecular genetics and bioinformatics have enabled the identification of a wide range of diagnostic, prognostic, and predictive biomarkers, which can be analyzed not only in tumor tissue samples but also in peripheral blood. the purpose of the study was to analyze and summarize current scientific and practical data in the field of non-invasive cancer screening using molecular biological analysis, development of innovative test systems and diagnostic kits, as well as issues of legal regulation and integration into medical and social insurance programs.

Material and Methods

Material and Methods. The study was based on Russian and international scientific databases, including the National Library of Medicine using the PubMed electronic resource, Elibrary, and Google scholar search results. Open internet resources were also searched using the keywords: cancer; malignant neoplasm; tumor; diagnostic; non-invasive; early; blood; Blood-based tests; test system; screening; pancancer; multi-cancer; sequencing; PCR; marker; DNA; cfDNA; multi-cancer early detection; MCED. The analytical review included clinical trial reports, meta-analyses, systematic reviews, and cohort randomized trials for the period 2008–2025.

Results

Results. There is a steady trend worldwide towards the widespread adoption of universal, non-invasive methods for early cancer diagnosis. Retrospective and prospective multicenter studies and meta-analyses conducted over the past 15 years have demonstrated advances in interdisciplinary multimodal analysis of diverse patient data (clinical, genomic, transcriptomic, epigenomic, etc.), emphasizing the cost-effectiveness of these methods.

Conclusion

Conclusion. Currently, large-scale population-based studies considering race and ethnicity are vital for validating methodological approaches and evaluating the effectiveness of non-invasive cancer screening methods, especially in diverse nations like Russia.

ракнеинвазивнаяранняяДНК-диагностикакровьскринингтест-системамаркерсеквенированиеПЦРcancernon-invasiveearlyDNA diagnosticsbloodscreeningtest systemMCEDcfDNAРабота выполнена в рамках предоставления субсидии «Гранты на проведение совместно с иностранными организациями научных исследований по программе двухи многостороннего научнотехнологического взаимодействия» при финансовой поддержке Министерства науки и высшего образования Российской Федерации (соглашение № 075-15-2025-650, проект № 13.2251.21.0289).This work was supported by the “Grants for Joint Scientific Research with Foreign Organizations under the Bilateral and Multilateral Scientific and Technological Cooperation Program” grant, with financial support from the Ministry of Science and Higher Education of the Russian Federation (agreement No. 075-15-2025650, project No. 13.2251.21.0289)ReferencesWorld Health Organization. Cancer prevention and control in the context of an integrated approach. 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The authors declare that there are no conflicts of interest present.