1. Diagnostic performance of p16/Ki-67 dual immunostaining at different number of positive cells in cervical smears in women referred for colposcopyUršula Salobir Gajšek, Andraž Dovnik, Iztok Takač, Urška Ivanuš, Tine Jerman, Simona Šramek Zatler, Alenka Repše-Fokter, 2021, original scientific article Abstract: . The aim of the study was to evaluate the diagnostic accuracy of p16/Ki-67 dual immunostaining (p16/ Ki-67 DS) in cervical cytology and the number of positive p16/Ki-67 cells to diagnose high grade cervical intraepithelial neoplasia (CIN2+) in colposcopy population. Subjects and methods. We performed an analysis on a subset cohort of 174 women enrolled within a large-scale randomised controlled human papillomavirus (HPV) self-sampling project organised as part of the population-based Cervical Cancer Screening Programme ZORA in Slovenia. This subset cohort of patients was invited to the colposcopy clinic, underwent p16/Ki-67 DS cervical cytology and had the number of p16/Ki-67 positive cells determined. Results. Among analysed women, 42/174 (24.1%) had histologically confirmed CIN2+. The risk for CIN2+ was increasing with the number of positive cells (p < 0.001). The sensitivity of p16/Ki-67 DS for detection of CIN2+ was 88.1%, specificity was 65.2%, positive predictive value was 44.6% and negative predictive value was 94.5%. Conclusions. Dual p16/Ki-67 immunostaining for the detection of CIN2+ has shown high sensitivity and high negative predictive value in our study, which is comparable to available published data. The number of p16/Ki-67 positive cells was significantly associated with the probability of CIN2+ detection. We observed a statistically significant and clinically relevant increase in specificity if the cut-off for a positive test was shifted from one cell to three cells.
Keywords: cervical cytology, high-grade dysplasia, p16/Ki-67 immunostaining
Published in DiRROS: 22.07.2024; Views: 55; Downloads: 8
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2. Long term results of follow-up after HPV self-sampling with devices Qvintip and HerSwab in women non-attending cervical screening programmeTeodora Bokan, Urška Ivanuš, Tine Jerman, Iztok Takač, Darja Arko, 2021, original scientific article Abstract: We are presenting the results of the Slovenian human papillomaviruses (HPV) self-sampling pilot study in colposcopy population of National Cervical Cancer Screening Programme ZORA for the first time. One-year and four-year follow-up results are presented for two different self-sampling devices. Participants and methods. A total of 209 women were enrolled in the study at colposcopy clinic. Prior to the gynaecological examination, all women performed self-collected vaginal swab at the clinic; 111 using Qvintip and 98 using HerSwab self-sampling device. After self-sampling, two cervical smears were taken by a clinician; first for conventional cytology and second for HPV test. After that, all women underwent colposcopy and a cervical biopsy if needed. We compared sensitivity, specificity, and predictive values of cytology (at the cut-off atypical squamous cells of undetermined significance or more [ASC-US+]) and HPV test (on self- and clinician-taken samples) for the detection of cervical intraepithelial neoplasia grade 2 or more (CIN2+) after one and four years of follow-up. Hybrid Capture 2 (HC2) assay was used for all HPV testing. Results. The mean age of 209 women was 37.6 years and HPV positivity rate 67.0% (140/209), 36.9 years and 70.3% (78/111) in the Qvintip group and 38.4 years and 63.3% (62/98) in the HerSwab group, respectively. Overall, percent agreement between self and clinician-taken samples was 81.8% (kappa 0.534) in the Qvintip and 77.1% (kappa 0.456) in the HerSwab group. In the Qvintip group, the longitudinal sensitivity, specificity, positive and negative predictive values were 71.8%, 75.0%, 83.6%, 60.0% for cytology; 83.1%, 51.3%, 75.6% and 62.5% for HPV test of self-taken samples and 94.4%, 57.5%, 79.8% and 85.2% for HPV test on clinician-taken samples. In the HerSwab group, the corresponding results were 71.7%, 46.7%, 61.3%, 58.3% for cytology; 75.0%, 47.7%, 62.9% and 61.8% for HPV test on self-taken samples and 94.3%, 44.4%, 66.7% and 87.0% for clinician-taken samples, respectively. Conclusions. The results confirm that HPV self-sampling is not as accurate as clinician sampling when HC2 is used. All HPV tests showed a higher sensitivity in detecting CIN2+ compared to cytology. Due to non-inferior longitudinal sensitivity of HPV self-sampling compared to cytology, HPV self-sampling might be an option for non-attenders to the National Cancer Screening Programme.
Keywords: HPV self-sampling, cytology, high-grade intraepithelial lesion, screening programmes
Published in DiRROS: 19.07.2024; Views: 84; Downloads: 26
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3. Evaluation of the training program for p16/ Ki-67 dual immunocytochemical staining interpretation for laboratory staff without experience in cervical cytology and immunocytochemistryVeronika Kloboves-Prevodnik, Živa Pohar-Marinšek, Janja Zalar, Hermina Rozina, Nika Kotnik, Tine Jerman, Jerneja Varl, Urška Ivanuš, 2020, original scientific article Abstract: ackground p16/Ki-67 dual immunocytochemical staining (DS) is considered easy to interpret if evaluators are properly trained, however, there is no consensus on what constitutes proper training. In the present study we evaluated a protocol for teaching DS evaluation on students inexperienced in cervical cytology. Methods Initial training on 40 DS conventional smears was provided by a senior cytotechnologist experienced in such evaluation. Afterwards, two students evaluated 118 cases. Additional training consisted mainly of discussing discrepant cases from the first evaluation and was followed by evaluation of new 383 cases. Agreement and accuracy of students' results were compared among the participants and to the results of the reference after both evaluations. We also noted time needed for evaluation of one slide as well as intra-observer variability of the teacher's results. Results At the end of the study, agreement between students and reference was higher compared to those after initial training (overall percent agreement [OPA] 81.4% for each student, kappa 0.512 and 0.527 vs. OPA 78.3% and 87.2%, kappa 0.556 and 0.713, respectively). However, accuracy results differed between the two students. After initial training sensitivity was 4.3% points and 2.9% points higher, respectively compared to the reference, while specificity was 30.6% points and 24.4% points lower, respectively, compared to the reference. At the end of the study, the sensitivity reached by one student was the same as that of the reference, while it was 2.6% points lower for the other student. There was a statistically significant difference in specificity between one student and the reference and also between students (16.7 and 15.1% points). Towards the end of the study, one student needed 5.2 min for evaluating one slide while the other needed 8.2 min. The intra-observer variability of the senior cytotechnologist was in the range of "very good" in both arms of the study. Conclusions In teaching DS evaluation, the students' progress has to be monitored using several criteria like agreement, accuracy and time needed for evaluating one slide. The monitoring process has to continue for a while after students reach satisfactory results in order to assure a continuous good performance. Monitoring of teacher's performance is also advisable.
Keywords: cervical cytology, cervical cancer, immunocytochemistry, accuracy
Published in DiRROS: 11.07.2024; Views: 102; Downloads: 59
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4. Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport MediumJerneja Varl, Urška Ivanuš, Živa Pohar-Marinšek, Tine Jerman, Anja Oštrbenk Valenčak, Mario Poljak, Veronika Kloboves-Prevodnik, 2019, original scientific article Keywords: Hybrid Capture 2, cervical cancer, HPV test, borderline results
Published in DiRROS: 05.07.2024; Views: 111; Downloads: 58
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5. Randomised trial of HPV self-sampling among non-attenders in the Slovenian cervical screening programme ZORA : comparing three different screening approachesUrška Ivanuš, Tine Jerman, Alenka Repše-Fokter, Iztok Takač, Veronika Kloboves-Prevodnik, Mateja Marčec, Uršula Salobir Gajšek, Maja Pakiž, Jakob Koren, Simona Hutter-Čelik, Kristina Gornik-Kramberger, Ulrika Klopčič, Rajko Kavalar, Simona Šramek Zatler, Biljana Grčar-Kuzmanov, Mojca Florjančič, Nataša Nolde, Srdjan Novaković, Mario Poljak, Maja Primic-Žakelj, 2018, original scientific article Published in DiRROS: 11.06.2024; Views: 148; Downloads: 84
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6. Cancer burden in Slovenia with the time trends analysisVesna Zadnik, Maja Primic-Žakelj, Katarina Lokar, Katja Jarm, Urška Ivanuš, Tina Žagar, 2017, original scientific article Abstract: Background The aim of our study was to describe cancer burden and time trends of all cancers combined, the most frequent as well as the rare cancers in Slovenia. Patients and methods The principal data source was the population-based Cancer Registry of Republic of Slovenia. The cancer burden is presented by incidence and prevalence for the period 1950%2013 and by mortality for years 1985%2013. The time trends were characterized in terms of an average annual percent change estimated by the log-linear joinpoint regression. The Dyba-Hakulinen method was used for estimation of incidence in 2016 and the projections of cancer incidence for the year 2025 were calculated applying the Globocan projection software. Results In recent years, near 14,000 Slovenes were diagnosed with cancer per year and just over 6,000 died; more than 94,000 people who were ever diagnosed with cancer are currently living among us. The total burden of cancer is dominated by five most common cancer sites: skin (non-melanoma), colon and rectum, lung, breast and prostate, together representing almost 60% of all new cancer cases. On average the incidence of common cancers in Slovenia is increasing for 3.0% per year in last decade, but the incidence of rare cancers is stable. Conclusions Because cancer occurs more among the elderly, and additionally more numerous post-war generation is entering this age group, it is expected that the burden of this disease will be growing further, even if the level of risk factors remains the same as today.
Keywords: cancer burden, cancer registry, incidence, prevalence
Published in DiRROS: 24.05.2024; Views: 223; Downloads: 196
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7. Javnozdravstveni vidik presejanja za pljučnega rakaUrška Ivanuš, 2023, published scientific conference contribution Abstract: Pljučni rak je pomemben javnozdravstveni problem, v Sloveniji vsak 5. bolnik, ki umre zaradi
raka, umre zaradi pljučnega raka in 5 let po diagnozi živi približno 1 od 5-ih bolnikov s
to diagnozo. Kljub napredku znanosti in tehnologije pljučnega raka najpogosteje odkrivamo
v napredovalem stadiju, ko je slabo ozdravljiv. Z uvedbo organiziranega populacijskega
presejanja za pljučnega raka lahko pljučnega raka odkrivamo bolj zgodaj, ko je zdravljenje
pomembno bolj uspešno. Dve večji metaanalizi sta ocenili, da bi umrljivost zaradi pljučnega
raka s presejanjem visoko ogroženih lahko zmanjšali nekje med 12 % in 21 %, nekoliko bolj
pri ženskah kot pri moških. V Evropi bi tako preprečili okrog 22.000 smrti zaradi pljučnega
raka letno. Nova priporočila Sveta Evropske unije z dne 9. decembra 2022 na področju
presejanja za raka državam članicam EU med drugim nalagajo, da premišljeno in postopno
preučijo izvedljivost in učinkovitost presejanja z nizkodoznim CT za presejanje oseb z
visokim tveganjem za pljučnega raka, vključno s trenutnimi in bivšimi hudimi kadilci. Pri tem
je potrebno načrtovati tudi tesno navezavo presejanja s strategijami in učinkovitimi ukrepi za
zmanjševanje razširjenosti kajenja. Slovenija se je na nova evropska priporočila za presejalne
programe za raka dobro pripravila. Pod okriljem Državne komisije za presejalne programe
se bomo pri uvajanju novih presejalnih programov oprli na znanstvene dokaze, mednarodna
priporočila in slovenske izkušnje, delovali bomo multidisciplinarno in vključevalno ter lovili
ravnotežje med pričakovanimi koristmi in škodo tovrstnega presejanja.
Keywords: pljučni rak, presejalni programi, bolniki
Published in DiRROS: 12.05.2023; Views: 534; Downloads: 144
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