Молодежный инновационный вестникМолодежный инновационный вестник2415-7805Федеральное государственное бюджетное образовательное учреждение высшего образования "Воронежский государственный медицинский университет имени Н.Н. Бурденко" Министерства здравоохранения Российской Федерации10514Conference ProceedingsEffectiveness of TruScreen in diagnosing precancer and cervical cancerRatnerSofya Andreevnaratner.s00@mail.ruhttps://orcid.org/0009-0005-5885-8805KhoperskayaOlga Viktorovnakhoperskaya88@bk.ruhttps://orcid.org/0000-0003-4199-8156YenkovaYelena Vladimirovnaenkova@bk.ruhttps://orcid.org/0000-0001-8885-1587Voronezh State Medical University named after N.N.Burdenko3006202514128322702202528022025Copyright © 2025, Ratner S.A., Khoperskaya O.V., Yenkova Y.V.2025<p>Cervical cancer (CC) is a malignant gynecological neoplasm and has long been ranked 5th (5.2%) in the structure of oncological morbidity in women, second only to 2 gynecological localizations and one of the leading causes of cancer mortality among young women. In the Russian Federation, according to 2018 data, 17,766 cases of the disease were identified, which is 22.3% more than in 2008 (13,807). In 2018, mortality from CC was 6,392, which puts this disease in 10th place in the structure of causes of cancer mortality in women. The peak incidence of CC, unlike other malignant neoplasms of the female genital tract, occurs at a younger age of 40 - 49 years (42.8 per 100 thousand of the corresponding population). Mortality rates from cervical cancer are steadily increasing, so there is a need to create new diagnostic methods that would allow determining changes in cervical tissues with high accuracy, for the early detection of pathological precancerous changes. TruScreen is a portable device for detecting cervical cancer, which was recognized by WHO in May 2019. This innovative scanner is capable of detecting cervical tissue damage, precancerous changes and cancerous processes with high accuracy in real time.</p>cervical cancercervical cancer diagnosticsTruScreenрак шейки маткидиагностика РШМTruScreen<p>Relevance: According to data for 2018, 17,766 cases of the disease were identified in the Russian Federation, which is 22.3% more than in 2008 (13,807). In 2018, mortality from cervical cancer (CC) was 6,392, which puts this disease in 10th place in the structure of causes of cancer mortality among women, along with breast cancer and ovarian cancer. About half of patients with CC die annually from the number of newly registered cases [1]. Early diagnosis will reduce mortality and obtain a favorable prognosis with timely treatment. TruScreen allows for early detection of precancerous changes and cancer processes, has a high speed of obtaining results and is informative.<br />Objective: to present an overview of the effectiveness and feasibility of using TruScreen in the diagnosis of precancerous conditions of the cervix. Materials and methods: a review of recent literature was conducted, assessing the effectiveness of using TruScreen in clinical practice, the informativeness of this study and the ease of its use.<br />Study results: Cervical cancer (CC) is a malignant tumor originating from the mucous membrane of the cervix (ectocervix or endocervix), which is sporadic in nature [1]. The development of this disease is not associated with hereditary syndromes. The cause of CC is the human papillomavirus (HPV) of a highly oncogenic type, as a rule, HPV 16 and / or 18 genotypes are detected in patients with CC [2]. There are a large number of risk factors for the development of this disease, such as early onset of sexual activity, smoking, frequent change of sexual partners, refusal of "barrier" type contraceptives, immunosuppression, the issue of the influence of various sexually transmitted infections is discussed [1]. Cervical cancer is the leading cause of cancer mortality in low- and middle-resource countries [3].<br />In the Russian Federation, 17,766 cases of the disease were identified in 2018, which is 22.3% more than in 2008 (13,807). In 2018, cervical cancer mortality was 6,392, which puts this disease in 10th place in the structure of causes of cancer mortality in women [4].<br />The practical guideline of the Journal of the National Comprehensive Cancer Network (2019) provides the following definition of cervical cancer - it is a malignant epithelial tumor that forms in the cervix. The source indicates that in most cases, cervical cancer can be prevented through regular screening and treatment of precancerous lesions. However, due to insufficient screening protocols, cervical cancer remains one of the common causes of cancer mortality among women [5]. Currently, HPV genotype testing and cytology are used for cervical cancer screening. For patients with an ASCUS (atypical squamous cells of undetermined significance) result, which is an inconclusive indication of the presence of a lesion, the HPV test will be the preferred method for subsequent evaluation. If the HPV test is negative, screening tests should be repeated after 3 years. If the HPV test result is positive, colposcopy should be performed [6] [7]. Cervical cancer responds well to treatment at the microinvasive stage. Therefore, there is always a need for a diagnostic method that allows detecting pathological changes in tissues at the early stages of disease development. An ideal screening test is characterized by high information content, ease of use, non-invasiveness, cost-effectiveness and high speed of obtaining results. Despite the fact that TruScreen was created under the guidance of leading medical scientists from the University of Sydney (Australia) back in 2004, it did not find its place among the screening protocols for cervical cancer until the draft clinical guidelines for the diagnosis and treatment of cervical neoplasia were written in 2024, where the method is recommended as a screening test in the absence of laboratory diagnostics [8].<br />The diagnostic method is based on differences in the optical and electrical capacitive resistance of normal and pathologically altered tissues. At the same time, the device generates weak electrical and light signals for examining cervical tissues, making contact of the manual sensor probe with the surface of the cervix.<br />Diagnostic value and effectiveness of the method<br />The real-time diagnostic method was a promising way to detect pathological changes in the tissues of the cervix. An obvious advantage over other screening tests is the speed of the procedure, independence from the availability of a laboratory, obtaining the result immediately after examining the surface of the exocervix. Currently, the Pap smear (Pap test) is used to diagnose precancerous and cancerous changes in the cervix, which is quite effective in detecting pathological changes in the epithelium of the cervix - cervical intraepithelial neoplasia of varying severity.The test provides information on the state of the epithelium in the endocervix and exocervix, as well as detailed and relevant information necessary for further development of a recommendation plan. TruScreen as an optoelectronic method cannot be used to assess tissue in the endocervix. Accordingly, clinically effective use of this method is possible in combination with cytological examination during primary screening, to make further decisions on patient management.<br />It is worth paying attention to the work of Barbara Suchońska et al. (Poland, 2021), which evaluates the optoelectronic diagnostic method for real-time CIN over four years of observation. The study assessed the ability of TruScreen to detect abnormal results in 130 women with abnormal Pap test results. Normal results after examination of the cervix using the TruScreen scanner were found in 68 patients (52.3%), abnormal results were found in 58 patients (44.6%) and 4 results were undetectable (3.1%). CIN lesions were diagnosed in 26 patients with an abnormal TruScreen cervical examination result. Among the 14 CIN cases not diagnosed by TruScreen (negative or inadequate result), there were 8 CIN 1 and 6 CIN 2+ cases. Four patients with an abnormal Pap smear, normal TruScreen result and normal histopathology result developed CIN 1 during the 4-year follow-up period. This study supports the use of cytology in combination with TruScreen [9]. Of interest is the study conducted by Yingting Wei et al. (2021), which clinically evaluates the TruScreen method in cervical cancer screening. Over 14 months, from December 2018 to January 2020, 458 women (25-65 years old) were screened for cervical cancer. The study included HPV testing, cytology analysis, and testing using the TruScreen device. The primary objective was to determine the diagnostic value of TruScreen, both alone and in combination with the HPV test, for detecting CIN2+ and CIN3+. The study showed that TruScreen has a sensitivity of 83.78% and a specificity of 78.86% for detecting CIN2+. The specificity of TruScreen significantly exceeds the specificity of HPV testing and cytology. When used in women with a high risk of HPV, the combination of TruScreen and the HPV test showed higher specificity compared to the combination of the HPV test and cytology, with comparable sensitivity. Similar patterns were found in the diagnosis of CIN3+ [10]. It is worth paying attention to the analysis of data from another study conducted by Fengyi Xiao, Long Sui (2024) to evaluate a real-time optoelectronic method for detecting cervical intraepithelial neoplasia and cervical cancer in patients with different types of transformation zone. The study included 1908 women who underwent cytology, HPV testing, TruScreen and colposcopy. The effectiveness of these methods in detecting HSIL, AIS or more severe lesions, depending on the type of transformation zone (TZ), was assessed. In detecting HSIL and more severe lesions, the TruScreen indicators (sensitivity, specificity, PPV, NPV) were comparable with those of cytology. However, in women with type 3 CT, TruScreen demonstrated significantly better sensitivity (72.29% vs. 51.16%), specificity (67.59% vs. 59.59%), PPV (13.86% vs. 7.94%), and NPV (97.13% vs. 94.71%) than cytology. This suggests that TruScreen may be particularly useful for detecting cervical cancer in women with type 3 CT [11].<br />TruScreen in the screening system<br />In the study, Yueming Yang et al. (2024) demonstrated the optimal screening strategy including TruScreen, cytology, HPV testing, and colposcopy by retrospectively analyzing 2286 cervical biopsy specimens with CIN2+ lesions. HPV testing showed the highest sensitivity, but to increase the specificity of the method, cytology or optoelectronic method should be used before colposcopy and biopsy. This study suggests screening strategies adapted to different regions. TruScreen, as a non-invasive, portable and easy-to-use tool, may be a preferred option to replace cytology in health care facilities with limited resources and no laboratory [12].<br />Conclusion<br />The analysis shows that there is no universal approach to cervical cancer screening. The choice of the optimal strategy should be based on a combination of different methods, such as HPV testing, cytology and TruScreen, as well as on individual patient characteristics, including the type of transformation zone and the presence of risk factors. TruScreen has demonstrated its effectiveness as a stand-alone method or in combination with HPV testing, especially in situations where cytology is not available. Future research should be aimed at developing personalized screening protocols that take into account all available diagnostic tools.</p>1.Рак шейки матки. Клинические рекомендации 2023.2.Shaokai Zhang 1, Huifang Xu 1, Luyao Zhang 1, Youlin Qiao 1 2. Cervical cancer: Epidemiology, risk factors3.and screening. Chin J Cancer Res . 2020 Dec 31;32(6):720-728. doi: 10.21147/j.issn.1000-9604.2020.06.05.4.Sung H, Ferlay J, Siegel RL, et al: Global cancer statistics 2020: GLOBOCAN estimates of incidence and5.mortality worldwide for 36 cancers in 185 countries. 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PLoS One. 2021 Feb26.26;16(2):e0247702. doi: 10.1371/journal.pone.0247702. eCollection 2021.27.Yu Ma 1, Jiangli Di 1, Hui Bi 2, Qingping Zhao 3, Tianhua Qin 4, Wen Xu 5, Zhaoyang Liu 6, Nianhua Yi 7,28.Jing Zhao 8, Deping Zhou 9, Jiancui Chen 10, Qi Yang 1. Comparison of the detection rate of cervical lesion29.with TruScreen, LBC test and HPV test: A Real-world study based on population screening of cervical cancer30.in rural areas of China. PLoS One. 2020 Jul 7;15(7):e0233986. doi: 10.1371/journal.pone.0233986. eCollection31.2020.32.Материалы ХХI Международного Бурденковского научного Конгресса 24-26 апреля 2025 года33.32 Молодежный инновационный вестник Том 14, №1 202534.Fengyi Xiao 1, Long Sui 2. Evaluation of a real-time optoelectronic method for the detection of cervical35.intraepithelial neoplasia and cervical cancer in patients with different transformation zone types. 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