20.500.12556/DKUM-79160 Dolgoročni rezultati sledenja po samoodvzemu vzorca za test na okužbo z onkogenimi humanimi papilomavirusi z odvzemnikoma qvintip in herswab za neodzivnice presejalnega programa za rak materničnega vratu LONG TERM RESULTS OF FOLLOW-UP AFTER HPV SELF-SAMPLING WITH DEVICES QVINTIP AND HERSWAB FOR WOMEN NON-ATTENDING CERVICAL SCREENING PROGRAMME POVZETEK Izhodišča: Rak materničnega vratu lahko preprečimo z odkrivanjem predrakavih sprememb na materničnem vratu. Organiziran nacionalni program se v Sloveniji izvaja s citološkimi pregledi brisov materničnega vratu, vendar je za uspešnost ključna dovolj velika udeležba žensk, ki pa je v Sloveniji v nekaterih regijah, tudi v mariborski, prenizka, še posebej v starejših starostnih skupinah. Odkar je znano, da je ključni povzročitelj raka materničnega vratu persistentna okužba z onkogenimi tipi humanih papilomavirusov (HPV) se določanje prisotnosti HPV uporablja v okviru obravnave žensk s patološkimi izvidi brisov materničnega vratu, po svetu pa tudi kot primarna metoda presejanja. Raziskave v svetu kažejo, da lahko udeležbo žensk, ki se ginekoloških presejalnih pregledov ne udeležujejo, občutno povečamo, kadar jim ponudimo možnost, da vzorec za test na prisotnost HPV opravijo same doma z ustreznimi samo-odvzemniki. Podatki o tem, koliko je samo-odvzem za HPV zanesljiv za odkrivanje predrakavih sprememb na materničnem vratu, so v literaturi nasprotujoči. Namen naše raziskave je bil ugotoviti, ali je izvid pregleda samo-odvzetega vzorca za test HPV primerljiv z vzorcem, ki ga odvzame ginekolog in tudi, ali je primerljiv s citološkim izvidom brisa materničnega vratu ter dovolj zanesljiv kot samostojna metoda za odkrivanje predrakavih sprememb na materničnem vratu. Bolnice in metode: V prospektivno raziskavo smo vključili 209 žensk napotenih v kolposkopsko ambulanto v obdobju 2014 do 2016. Ob vključitvi v raziskavo so ženske najprej same iz nožnice odvzele vzorec za test na HPV z enim od samo-odvzemnikov. 111 jih je uporabilo samo-odvzemnik Qvintip, 98 pa HerSwab. Vsaka ženska je uporabila samo eno vrsto odvzemnika. Pri vseh je nato vzorec za HPV z materničnega vratu odvzel tudi ginekolog. Hkrati je odvzel bris materničnega vratu za citološko preiskavo, opravil kolposkopijo in po potrebni biopsijo materničnega vratu za histopatološko preiskavo. Pacientke smo za tem redno spremljali v kolposkopski ambulanti v skladu z nacionalnimi smernicami. Za določanje prisotnosti visoko rizičnih tipov HPV smo uporabljali Hybride Capture 2 Rezultate smo analizirali po enem in štirih letih od vključitve v raziskavo. Izračunali smo občutljivost, specifičnost, negativno napovedno vrednost in pozitivno napovedno vrednost samo-odvzetega vzorca za HPV, vzorca za HPV, ki ga je odvzel ginekolog in citologije za odkrivanje cervikalne intraepiteljiske neoplazije CIN 2 in več (CIN 2+) ter ujemanje testov za HPV. Rezultati: Povprečna starost vključenih žensk je bila 37,6 let, HPV je bil pozitiven pri 67,0 % (140/209). V skupini Qvintip je bila povprečna starost 36,9 let, HPV je bil pozitive pri 70,3 % (78/111), v skupini HerSwab pa 38,4 let in HPV pozitiven pri 63,3 % (62/98). Odstotek skupnega ujemanja med samo-odvzetim vzorcem in vzorcem, ki ga je odvzel ginekolog, je bil v skupini Qvintip 81,8 % (kappa 0,534) v skupini HerSwab pa 77,1 % (kappa 0,456). V skupini Qvintip so bile longitudinalna občutljivost, specifičnost, pozitivna in negativna napovedna vrednost za citologijo: 71,8 %, 75,0 %, 83,6 %, 60,0 %; za samo-odvzet HPV: 83,1 %, 51,3 %, 75,6 % in 62,5 % ter za HPV test, ki ga je odvzel ginekolog: 94,4 %, 57,5 %, 79,8 % in 85,2 %. V skupini HerSwab so bili rezultati istih parametrov: 71,7 %, 46,7 %, 61,3 %, 58,3 % za citologijo; 75,0 %, 47,7 %, 62,9 % in 61,8 % za samo-odvzet HPV in 94,3 %, 44,4 %, 66,7 % in 87,0 % za HPV, ki ga je odvzel ginekolog. Zaključki: Naši rezultati so pokazali, da je samo-odvzet vzorec za test na HPV, določen s HC2, manj zanesljiv od vzorca, ki ga odvzame zdravnik. So pa vsi HPV testi so pokazali višjo občutljivost v odkrivanju CIN2+ v primerjavi s citologijo, čeprav razlike niso bile statistično značilne. Glede na primerljivo občutljivost samo-odvzetega HPV s citologijo, bi bil samo-odvzem lahko primerna možnost za neodzivnice v nacionalnem presejalnem programu za raka materničnega vratu. ABSTRACT Baseline: Cervical cancer can be prevented by detecting precancerous lesions of the cervix. In Slovenia, a national screening program is available using cervical cytology smear tests. For the program to be successful, it is necessary to involve a sufficient number of women; however, some regions in Slovenia, including the Maribor region, do not reach the required threshold, especially older age groups. As the cause of cervical cancer is attributable to the persistent infection with oncogenic types of human papillomaviruses (HPV), detection the presence of HPV has been introduced globally as a primary screening method to treat women with cervical smear pathology. Research from around the world shows that the participation rate of non-attenders can be significantly increased by providing them an opportunity to self-collect cervical samples at home using a self-sampling device. In literature, there is no agreement on whether HPV self-sampling is a reliable method to detect cervical precancerous lesions. The aim of this study was to establish whether the result of the HPV testing of self-collected samples is comparable to the sample collected by a gynecologist and whether it is comparable to the cytological cervical smear result and sufficiently reliable as a stand-alone method to detect cervical precancerous abnormalities. Patients and methods: The prospective study included 209 women referred to a colposcopy clinic in the period from 2014 to 2016. Upon inclusion in the study, women self-collected a vaginal sample for an HPV test using a self-sampling device. 111 women used a Qvintip self-sampling device and 98 women used a HerSwab collector. Each woman used only one type of self-sampling device. All of them underwent a test collecting a cervical sample for HPV by a gynecologist. At the same time, they attended an exam for cervical cytology and colposcopy and, if necessary, a cervical biopsy for histopathology. The patients were then regularly followed at the colposcopy clinic according to national guidelines. Hybrid Capture 2 technology was used to determine the presence of high-risk HPV types. The results were analyzed one and four years after inclusion in the study. The sensitivity, specificity, negative predictive value, and positive predictive value of a self-collected HPV sample, an HPV sample collected by a gynecologist, and cytology to detect cervical intra-epithelial neoplasia (CIN 2) and above (CIN 2+) as well as HPV test matching were calculated. Results: The mean age of women involved in the study was 37.6 years, HPV was positive in 67.0% (140/209). The mean age in the Qvintip group was 36.9 years, HPV was positive in 70.3% (78/111). In the HerSwab group, the mean age was 38.4 years, HPV was positive in 63.3% (62/98). The total match percentage between the self-collecting sample and the sample collected by a gynecologist was 81.8% for the Qvintip group (kappa 0.534) and 77.1% for the HerSwab group (kappa 0.456). In the Qvintip group, longitudinal sensitivity, specificity, positive and negative predictive value for cytology were as follows: 71.8%, 75.0%, 83.6%, 60.0%; for self-collected HPV: 83.1%, 51.3%, 75.6%, and 62.5% and for the HPV test collected by a gynecologist: 94.4%, 57.5%, 79.8%, and 85.2%. In the HerSwab group, the results for the same parameters were as follows: 71.7%, 46.7%, 61.3%, 58.3% for cytology; 75.0%, 47.7%, 62.9%, and 61.8% for self-collected HPV and 94.3%, 44.4%, 66.7%, and 87.0% for HPV collected by a gynecologist. Conclusions: Our results showed that a self-collected HPV sample determined by HC2 was less reliable than a sample collected by a healthcare professional. However, all HPV tests showed a higher sensitivity in CIN2+ detection compared to cytology, although the differences were not statistically significant. Given the comparable sensitivity of self-obtained HPV specimens to cytology, self-collection for HPV might be a viable option for non-attending women in the nationa samo-odvzem za HPV citologija cervikalna intraepiteljiska neoplazija HPV self-sampling cytology cervical intraepithelial neoplasia true true false Slovenski jezik Angleški jezik Doktorsko delo/naloga 2021-05-18 10:12:37 2022-02-04 14:49:05 2022-08-09 20:12:51 0000-00-00 00:00:00 2021 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 96441091 DOK_Bokan_Teodora_2022.pdf DOK_Bokan_Teodora_2022.pdf 1 01EFDFDA7F85585E9AD0FEEFD83C0296 86f16f656f954a851bb3f3deb4a2436f05d0c721e875143926c5022e85a982ed f8078984-7f48-11ec-9178-00155d000105 20.500.12556/dkum/81a06af5-31e3-4fc7-9655-771b6e930eff https://dk.um.si/Dokument.php?lang=slv&id=156299 Medicinska fakulteta 0 0 0