Introduction/Background Cervical intraepithelial neoplasia (CIN) grade 2 is considered a high-grade squamous intraepithelial lesion requiring surgical treatment. Excisional cervical procedures, though, have been linked to an increased risk of preterm birth in subsequent pregnancies. Therefore, and given the fact that the vast majority of CIN2 cases will regress, there is a tendency to avoid surgical treatment for women who wish fertility preservation. The aim of the CIN2DIN study is to determine the diagnostic accuracy of P16/Ki-67 immunocytochemistry (ICC) for the timely detection of CIN3+, among women with untreated CIN2, compared to cytology.
Methodology According to the study design, women with biopsy confirmed CIN2, after written informed consent, will be subjected to cervicovaginal sampling for p16/Ki-67 ICC (CINtec PLUS, Roche laboratories AG, Mannheim, Germany), cytology and high-risk Human Papillomavirus (hrHPV) testing (cobas® HPV Test, Roche Molecular Systems, Pleasanton, CA, USA) (t=0). After six months (t=1), participants will be subjected to colposcopy, and, cervicovaginal sampling for cytology and p16/Ki-67 ICC. After 12 months (t=2) participants will be subjected to colposcopy, and, to cervicovaginal sampling for hrHPV testing, cytology and p16/Ki-67 ICC. Participants will be also examined after 18 and 24 months (t=3, t=4, respectively). Examinations at t=3 and t=4 will be similar to t=1, and t=2 respectively. All women after visit t=4 exit the study and are referred to treatment according to the local guidelines.
Results To date 5 women with biopsy proven CIN2 have been recruited. Those women have been subjected to pap test, hrHPV testing, and p16/Ki-67 ICC.
Conclusion The CIN2DIN study is original and innovative. So far, no studies have been conducted on the value of P16/Ki-67 ICC for CIN2 surveillance. If the study identifies high correlation of P16/Ki-67 ICC to colposcopy, larger studies could be designed to investigate longer-term reassurance for the surveillance of women with untreated CIN2 without colposcopy.
Disclosures The authors have nothing to disclose
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