medalphabetМедицинский алфавитMedical alphabet2078-56312949-2807ООО «Альфмед»10.33667/2078-5631-2024-4-17-21medalphabet-3663Research ArticleСтатьиСА-125 в популяционном скрининге и персонализированном мониторингеCA-125 in population screening and personalized monitoringhttps://orcid.org/0000-0002-0482-0802КовязинаН. А.KovyazinaN. A.

Ковязина Надежда Алексеевна, д. м. н., заведующая лабораторией серологических исследований и аллергодиагностики отдела лабораторной диагностики

Санкт-Петербург

Kovyazina Nadezhda A., DM Sci (habil.), head of the Laboratory of Serological Research and Allergy Diagnostics of Dept of Laboratory Diagnostics

Saint-Petersburg

nakovzn@gmail.comhttps://orcid.org/0000-0002-6268-8969АлхутоваН. А.AlkhutovaN. A.

Алхутова Наталья Александровна, к. б. н., старший научный сотрудник научно-исследовательского отдела лабораторной диагностики научно-исследовательского центра

Санкт-Петербург

Alkhutova Natalya A., PhD Bio Sci, senior researcher at the Research Dept of Laboratory Diagnostics of the Research Center

Saint-Petersburg

nalhutova@yandex.ruЖижинаО. Л.ZhizhunaO. L.

Жижина Ольга Леонидовна, к. м. н., доцент кафедры пропедевтики внутренних болезней

Санкт-Петербург

Zhizhina Olga L., PhD Med, associate professor at Dept of Propaedeutics of Internal Diseases

Saint-Petersburg

zhizhuna-o@mail.ruhttps://orcid.org/0000-0001-6998-1669АлексанинС. С.AleksaninS. S.

Алексанин Сергей Сергеевич, д. м. н., профессор, член-корреспондент РАН, директор

Санкт-Петербург

Aleksanin Sergey S., DM Sci (habil.), professor, Corresponding Member of the Russian Academy of Sciences, director

Saint-Petersburg

medicine@nrcerm.ruФГБУ «Всесоюзный Центр Экстренной и Радиационной Медицины им. А. М. Никифорова» Министерства Российской Федерации по делам Гражданской обороны, чрезвычайным ситуациям и ликвидации последствий стихийных бедствийРоссияNikiforov Russian Center of Emergency and Radiation MedicineRussian FederationФГБОУ ВО «Санкт-Петербургский государственный университет»РоссияSaint Petersburg State UniversityRussian Federation20240905202404Современная лаборатория (1)1721Copyright © Ковязина Н.А., Алхутова Н.А., Жижина О.Л., Алексанин С.С., 20242024Ковязина Н.А., Алхутова Н.А., Жижина О.Л., Алексанин С.С.Kovyazina N.A., Alkhutova N.A., Zhizhuna O.L., Aleksanin S.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-alphabet.com/jour/article/view/3663

Повышенный уровень СА-125 в подавляющем большинстве случаев связан с патологическим процессом различной локализации, онкологической и неонкологической этиологии. Обнадеживающие данные о клинической информативности СА-125 и простота его лабораторного определения являются поводом для многолетней дискуссии об использования этого маркера не только для оценки динамики течения рака яичников, но и в популяционном скрининге, а также при персонализированном наблюдении за состоянием здоровья женщин. В статье обосновано включение СА-125 в алгоритмы персонализированного наблюдения за состоянием здоровья женщин и современные аспекты постаналитической оценки результатов тестирования: оценка неопределенности измерения, выявление достоверной динамики между последовательными результатами и использование нескольких границ принятия клинического решения. Предложена форма развернутого отчета о выполненном лабораторном исследовании.

The increased level of CA-125 in the vast majority of cases is associated with the pathological process of both oncological and non-oncological etiology. Encouraging data on the clinical informativeness of CA-125 and the simplicity of its laboratory determination are the reason for a long-term discussion about the use of this marker not only for assessing the dynamics of ovarian cancer, but also in population screening, as well as in personalized monitoring of women’s health. The article substantiates the inclusion of CA-125 in algorithms for personalized monitoring of women’s health and modern aspects of post-analytical evaluation of test results: assessment of measurement uncertainty, identification of reliable dynamics between successive results and the use of multiple boundaries of clinical decision. The form of a detailed report on the performed laboratory study is proposed.

СА-125постаналитическая оценканеопределенность измеренияотчет о лабораторном исследованииCA-125post-analytical assessmentmeasurement uncertaintylaboratory test reportReferencesSources of variation and establishment of Russian reference intervals for major hormones and tumor markers / A. Ruzhanskaya, K. Ichihara, S. Evgina, I. Skibo, N. Vybornova, A. Vasiliev, G. Agarkova, V. Emanuel // PLoS One. 2021. – Vol. 16. – No. 1. – P. e0234284. DOI: 10.1371/journal.pone.0234284.Sources of variation and establishment of Russian reference intervals for major hormones and tumor markers / A. Ruzhanskaya, K. Ichihara, S. Evgina, I. Skibo, N. Vybornova, A. Vasiliev, G. Agarkova, V. Emanuel // PLoS One. 2021. – Vol. 16. – No. 1. – P. e0234284. DOI: 10.1371/journal.pone.0234284.Онкология: Национальное руководство. Краткое издание / под ред. В. И. Чиссова, М. И. Давыдова. Москва: ГЭОТАР-Медиа, 2017. 576 с. ISBN 978–5–9704–3982–1.Onkologiya: Nacional’noe rukovodstvo. Kratkoe izdanie. V. I. Chissov, M. I. Davydov (ed.). Moscow: GEOTAR-Media, 2017. 576 p. ISBN 978–5–9704–3982–1. (In Russ.)Tuxen, M. K. Tumor marker CA125 in ovarian cancer / M. K. Tuxen // Journal of Tumor Marker Oncology. 2001. – Vol. 16. – No. 1. – P. 49–67.Tuxen, M. K. Tumor marker CA125 in ovarian cancer / M. K. Tuxen // Journal of Tumor Marker Oncology. 2001. – Vol. 16. – No. 1. – P. 49–67.Behnamfar, F. Are ROMA and HE 4 more accurate than CA-125, in predicting of ovarian epithelial carcinoma? / F. Behnamfar, A. Zafarbakhsh, N. Ahmadian // Advanced Biomedical Research. 2023. – 2:156. DOI: 10.4103/abr.abr_264_22.Behnamfar, F. Are ROMA and HE 4 more accurate than CA-125, in predicting of ovarian epithelial carcinoma? / F. Behnamfar, A. Zafarbakhsh, N. Ahmadian // Advanced Biomedical Research. 2023. – 2:156. DOI: 10.4103/abr.abr_264_22.Clinical Use of Cancer Biomarkers in Epithelial Ovarian Cancer: Updated Guidelines From the European Group on Tumor Markers. The International Journal of Gynecological Cancer / G. Sölétormos, M. J. Duffy, Abu Hassan S. Othman, R. H. Verheijen, B. Tholander, R. C. Jr. Bast, K. N. Gaarenstroom, C. M. Sturgeon, J. M. Bonfrer, P. H. Petersen, H. Troonen, G. Carlo-Torre, J. Kanty Kulpa, M. K. Tuxen, R. Molina. 2016. – Vol. 26. – No. 1. – P. 43–51. DOI: 10.1097/IGC.0000000000000586.Clinical Use of Cancer Biomarkers in Epithelial Ovarian Cancer: Updated Guidelines From the European Group on Tumor Markers. The International Journal of Gynecological Cancer / G. Sölétormos, M. J. Duffy, Abu Hassan S. Othman, R. H. Verheijen, B. Tholander, R. C. Jr. Bast, K. N. Gaarenstroom, C. M. Sturgeon, J. M. Bonfrer, P. H. Petersen, H. Troonen, G. Carlo-Torre, J. Kanty Kulpa, M. K. Tuxen, R. Molina. 2016. – Vol. 26. – No. 1. – P. 43–51. DOI: 10.1097/IGC.0000000000000586.Клиническая значимость биологических маркеров при раке яичников, раке предстательной железы, колоректальном раке / Н. В. Маршутина, М. П. Солохина, И. И. Алентов, Н. С. Сергеева // Исследования и практика в медицине. 2016. – Т. 3. – № 1. – С. 46–57.Clinical significance of biomarkers in ovarian cancer, prostate cancer, colorectal cancer / N. V. Marshutina, M. P. Solokhina, I. I. Alentov, N. S. Sergeeva // Research and Practical Medicine Journal. 2016. – Vol. 3. – No. 1. – P. 46–57. (In Russ.)Stewart, C. Ovarian Cancer: An Integrated Review / C. Stewart, C. Ralyea, S. Lockwood // Seminars Oncology Nursing. 2019. – Vol. 35. – No. 2. – P. 151–156. DOI: 10.1016/j.soncn.2019.02.001.Stewart, C. Ovarian Cancer: An Integrated Review / C. Stewart, C. Ralyea, S. Lockwood // Seminars Oncology Nursing. 2019. – Vol. 35. – No. 2. – P. 151–156. DOI: 10.1016/j.soncn.2019.02.001.Сергеева, Н. С. Опухолеассоциированные маркеры в скрининговых программах, направленных на активное выявление рака яичников: реальность, проблемы и перспективы / Н. С. Сергеева, Н. В. Маршутина // Практическая онкология. 2010. – Т. 11. – № 2. – С. 109–118.Marshutina, N. V. Opuholeassociirovannye markery v skriningovyh programmah, napravlennyh na aktivnoe vyyavlenie raka yaichnikov: real’nost’, problemy i perspektivy / N. V. Marshutina, N. S. Sergeeva // Practical oncology. 2010. – Vol. 11. – No. 2. – P. 109–118. (In Russ.)Esmo Guidelines Task Force. ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of ovarian cancer / Esmo Guidelines Task Force // Annals of Oncology. 2001. – Vol. 12. – No. 9. – P. 1205–1207.Esmo Guidelines Task Force. ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of ovarian cancer / Esmo Guidelines Task Force // Annals of Oncology. 2001. – Vol. 12. – No. 9. – P. 1205–1207.Montagnana, M. Circulating biomarkers in epithelial ovarian cancer diagnosis: from present to future perspective / M. Montagnana, M. Benati, E. Danese // The Annals of Translational Medicine. 2017. – Vol. 5. – No. 13. – P. 276.Montagnana, M. Circulating biomarkers in epithelial ovarian cancer diagnosis: from present to future perspective / M. Montagnana, M. Benati, E. Danese // The Annals of Translational Medicine. 2017. – Vol. 5. – No. 13. – P. 276.Перспективы ранней диагностики рака яичников / Л. А. Ашрафян, И. Б. Антонова, О. И. Алешикова, Н. А. Бабаева, С. В. Ивашина, А. В. Люстик, Е. В. Герфанова // Вестник Российского научного центра рентгенорадиологии Минздрава России. URL: http://vestnik.rncrr.ru/vestnik/v14/papers/aleshikova_v14.pdfProspects of early diagnosis of ovarian cancer / L. Ashrafian, I. Antonova, O. Aleshikova, N. Babayeva, S. Ivashina, A. Liustik, E. Gerfanova // Vestnik Rossijskogo nauchnogo centra rentgenoradiologii Minzdrava Rossii. URL: http://vestnik.rncrr.ru/vestnik/v14/papers/aleshikova_v14.pdf (In Russ.)HE 4 in ovarian cancer: from discovery to clinical application / M. Montagnana, E. Danese, S. Giudici, M. Franchi, G. C. Guidi, M. Plebani, G. Lippi // Advances in Clinical Chemistry. 2011. – Vol. 55. – P. 1–20.HE 4 in ovarian cancer: from discovery to clinical application / M. Montagnana, E. Danese, S. Giudici, M. Franchi, G. C. Guidi, M. Plebani, G. Lippi // Advances in Clinical Chemistry. 2011. – Vol. 55. – P. 1–20.Relationship among surgical complexity, short-term morbidity, and overall survival in primary surgery for advanced ovarian cancer / G. D. Aletti, S. C. Dowdy, K. C. Podratz, W. A. Cliby // American Journal of Obstetrics and Gynecology. 2007. – Vol. 197. – No. 6. – P. 676.e1–7.Relationship among surgical complexity, short-term morbidity, and overall survival in primary surgery for advanced ovarian cancer / G. D. Aletti, S. C. Dowdy, K. C. Podratz, W. A. Cliby // American Journal of Obstetrics and Gynecology. 2007. – Vol. 197. – No. 6. – P. 676.e1–7.Tumour markers in gynaecological cancers – EGTM recommendations. European Group on Tumor Markers. Anticancer Research / O. Segurado, J. Вonfrer, М. J. Duffy [et al.] 1999. – Vol. – No. 4. – P. 2807–1280.Tumour markers in gynaecological cancers – EGTM recommendations. European Group on Tumor Markers. Anticancer Research / O. Segurado, J. Вonfrer, М. J. Duffy [et al.] 1999. – Vol. – No. 4. – P. 2807–1280.CA125 expression pattern, prognosis and correlation with serum CA125 in ovarian tumor patients. From The Danish “MALOVA” Ovarian Cancer Study / E. V. Høgdall, L. Christensen, S. K. Kjaer [et al.] // Gynecologic Oncology. 2007. – Vol. 104. – No. 3. – P. 508–515.CA125 expression pattern, prognosis and correlation with serum CA125 in ovarian tumor patients. From The Danish “MALOVA” Ovarian Cancer Study / E. V. Høgdall, L. Christensen, S. K. Kjaer [et al.] // Gynecologic Oncology. 2007. – Vol. 104. – No. 3. – P. 508–515.Advances in diagnosis and management of ovarian cancer. S. A. Farghaly (ed.). New York: 2014. P. 33–58. ISBN: 978–1–4614–8270–3Advances in diagnosis and management of ovarian cancer. S. A. Farghaly (ed.). New York: 2014. P. 33–58. ISBN: 978–1–4614–8270–3National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers / C. M. Sturgeon, M. J. Duffy, U. H. Stenman [et al.] // Clinical Chemistry. 2008. – Vol. 54. – No. 12. – P. e11–79.National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers / C. M. Sturgeon, M. J. Duffy, U. H. Stenman [et al.] // Clinical Chemistry. 2008. – Vol. 54. – No. 12. – P. e11–79.Audit of transvaginal sonography of normal postmenopausal ovaries by sonographers from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) / W. Stott, A. Gentry-Maharaj, A. Ryan, N. Amso, M. Seif, C. Jones, I. Jacobs, M. Parmar, U. Menon, S. Campbell, M. Burnell. F1000Res. 2018. – No. 7. – 1241p.Audit of transvaginal sonography of normal postmenopausal ovaries by sonographers from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) / W. Stott, A. Gentry-Maharaj, A. Ryan, N. Amso, M. Seif, C. Jones, I. Jacobs, M. Parmar, U. Menon, S. Campbell, M. Burnell. F1000Res. 2018. – No. 7. – 1241p.Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening / U. Menon, A. Ryan, J. Kals [et al.] // Journal of Clinical Oncology. 2015. – Vol. 33. – No. 18. – P. 2062–2071.Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening / U. Menon, A. Ryan, J. Kals [et al.] // Journal of Clinical Oncology. 2015. – Vol. 33. – No. 18. – P. 2062–2071.Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial / I. J. Jacobs, U. Menon, A. Ryan [et al.] // Lancet. 2016. – Vol. 387. – P. 945–956.Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial / I. J. Jacobs, U. Menon, A. Ryan [et al.] // Lancet. 2016. – Vol. 387. – P. 945–956.The cost-effectiveness of screening for ovarian cancer: Results from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) / U. Menon, A. J. McGuire, M. Raikou [et al.] // British Journal of Cancer. 2017. – Vol. 117. – No. 5. – P. 619–627.The cost-effectiveness of screening for ovarian cancer: Results from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) / U. Menon, A. J. McGuire, M. Raikou [et al.] // British Journal of Cancer. 2017. – Vol. 117. – No. 5. – P. 619–627.Husseinzadeh, N. Status of tumor markers in epithelial ovarian cancer has there been any progress? A review / N. Husseinzadeh // Gynecologic Oncology. 2011. – Vol. 120. – No. 1. – P. 152–157.Husseinzadeh, N. Status of tumor markers in epithelial ovarian cancer has there been any progress? A review / N. Husseinzadeh // Gynecologic Oncology. 2011. – Vol. 120. – No. 1. – P. 152–157.Reducing ovarian cancer mortality through screening: Is it possible, and can we afford it? / L. J. Havrilesky G. D., Sanders, S. Kulasingam, E. Myers R. // Gynecologic Oncology. 2008. – Vol. 111. – № 2. – P. 179–87. DOI: 10.1016/j.ygyno.2008.07.006.Reducing ovarian cancer mortality through screening: Is it possible, and can we afford it? / L. J. Havrilesky G. D., Sanders, S. Kulasingam, E. Myers R. // Gynecologic Oncology. 2008. – Vol. 111. – № 2. – P. 179–87. DOI: 10.1016/j.ygyno.2008.07.006.Клиническая значимость ПСА-ассоциированных тестов в диагностике и стадировании рака предстательной железы / Н. С. Cергеева, Т. Е. Скачкова, Н. В. Маршутина, Б. Я. Алексеев, А. Д. Каприн // Онкология. Журнал им. П. А. Герцена. 2018. – № 1. – С. 55–67. DOI: 10.17116/onkolog20187155–67Kaprin Clinical significance of PSA-associated tests in the diagnosis and staging of prostate cancer / N. S. Sergeeva, T. E. Skachkova, N. V. Marshutina, B. Ia. Alekseev, A. D. // P. A. Herzen Journal of Oncology. 2018. – No. 1. – P. 55–67. (In Russ.)Семенов, Н. Н. Повышенный уровень СА125 (МUC 16) при метастатическом раке желудка – мощный фактор негативного прогноза выживаемости / Н. Н. Семёнов, К. Д. Далгатов //Злокачественные опухоли. 2022. – Т. 12. – № 1. С. 44–50. DOI: 10.18027/2224–5057–2022–12–1–44–50.Semenov, N. N. Elevated levels of CA125 (MUC 16) in metastatic gastric cancer as a strong predictor of poor survival / N. N. Semenov, K. Dalgatov //Malignant tumours. 2022. – Vol. 12. – No. 1. – P. 44–50. DOI: 10.18027/2224–5057–2022–12–1–44–50. (In Russ.)CA125: A superior prognostic biomarker for colorectal cancer compared to CEA, CA19–9 or CA242 / K. Björkman, H. Mustonen, T. Kaprio, H. Kekki, K. Pettersson, C. Haglund, C. Böckelman // Tumour Biology. 2021. – Vol. 43- No. 1. – P. 57–70. DOI: 10.3233/TUB-200069.CA125: A superior prognostic biomarker for colorectal cancer compared to CEA, CA19–9 or CA242 / K. Björkman, H. Mustonen, T. Kaprio, H. Kekki, K. Pettersson, C. Haglund, C. Böckelman // Tumour Biology. 2021. – Vol. 43- No. 1. – P. 57–70. DOI: 10.3233/TUB-200069.CA-125 variation in acute heart failure: a single-centre analysis / Patrícia Lourenço, Filipe M. Cunha, Catarina Elias, Catarina Fernandes, Isaac Barroso, João T. Guimarães, Paulo Bettencourt // ESC Heart Failure. 2022. – № 9. – P. 1018–1026. DOI: 10.1002/ehf2.13758CA-125 variation in acute heart failure: a single-centre analysis / Patrícia Lourenço, Filipe M. Cunha, Catarina Elias, Catarina Fernandes, Isaac Barroso, João T. Guimarães, Paulo Bettencourt // ESC Heart Failure. 2022. – № 9. – P. 1018–1026. DOI: 10.1002/ehf2.13758Evaluation of serum and salivary ca-125 in breast cancer patients – an analytical study / Urvashee Dwivedi, Anurag Jain, Fatima Bhopalwala Ali, Mustafa Ali // Asian Journal of Pharmaceutics. 2023. – Vol. 16. – No. 4. – P. 97–99.Evaluation of serum and salivary ca-125 in breast cancer patients – an analytical study / Urvashee Dwivedi, Anurag Jain, Fatima Bhopalwala Ali, Mustafa Ali // Asian Journal of Pharmaceutics. 2023. – Vol. 16. – No. 4. – P. 97–99.Serum Markers CA125, CA153, and CEA along with Inflammatory Cytokines in the Early Detection of Lung Cancer in High-Risk Populations / G. Li, H. Zhang, L. Zhang, H. Liu, S. Li, Y. Wang, X. Deng // BioMed Research International. 2022. Article ID 1394042. – 4 p. DOI: 10.1155/2022/1394042.Serum Markers CA125, CA153, and CEA along with Inflammatory Cytokines in the Early Detection of Lung Cancer in High-Risk Populations / G. Li, H. Zhang, L. Zhang, H. Liu, S. Li, Y. Wang, X. Deng // BioMed Research International. 2022. Article ID 1394042. – 4 p. DOI: 10.1155/2022/1394042.Технология оценки неопределенности измерения: обоснование, условия и опыт внедрения в медицинскую практику / Н. А. Ковязина, Н. А. Алхутова, А. Г. Чуновкина, В. Л. Эмануэль // Медицинский алфавит. 2022. – № 19. – С. 7–11. DOI: 10.33667/2078–5631–2022–19–7–11Measurement uncertainty estimation technology: justification and experience of implementation in medical practice / N. A. Kovyazina, N. A. Alhutova, A. G. Chunovkina, V. L. Emanuel // Medical alphabet. 2022. – No. 19 – P. 7–11. DOI: 10.33667/2078–5631–2022–19–7–11Ковязина, Н. А. Биологическая вариация – вклад в клиническую неопределенность и роль в обеспечении качества количественных лабораторных исследований / Н. А. Ковязина, Н. А. Алхутова, С. С Алексанин // Менеджмент качества в медицине. 2023. – № 3. – С. 101–107.Kovyazina, N. A. Biological variation – contribution to clinical uncertainty and the role in quality ensuring of quantitative laboratory studies / N. A. Kovyazina, N. A. Alhutova, S. S. Aleksanin // Quality management in medicine. 2023. No. 3. P. 101–107. (In Russ.)МИ 3664–2022: рекомендация Государственной системы обеспечения единства измерений «Медицинские лаборатории. Оценивание неопределенности измерения при количественном иммунохемилюминесцентном анализе. Практическое руководство». 2022.MI 3664–2022: Recommendation of the State System for ensuring the Uniformity of Measurements ‘Medical laboratories. Estimation of measurement uncertainty in quantitative immunochemiluminescence analysis. Practical guide’. 2022. (In Russ.)

The authors declare that there are no conflicts of interest present.