Claudin1 as a Biomarker of Cervical Cytology and

Authors: Márta Benczik Ádám Galamb Róbert Koiss Attila Kovács Balázs Járay Tamás Székely Tímea Szekerczés Zsuzsa Schaff Gábor Sobel Csaba Jeney

Publish Date: 2015/10/13

Volume: 22, Issue: 1, Pages: 179-188

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Abstract

Several immunochemistry tests are used for triaging human papilloma virus HPV and cytology positive cases in cervical cancer screening and as an adjunct test to diagnose cervical cancer Claudin1 CLDN1 protein is a major component of the tight junction shown to have altered expression in cervical cancer In this study value of CLDN1 was analysed as a screening and triage immunochemistry test compared to cytology and HPV testing A population of 352 women attending colposcopic referral visits resulting in cervical conisation and a second population of 150 women attending routine gynaecological visits with negative cervical cytology were enrolled in a multicentre clinical study in Hungary Cytology and HPV Genoid Full Spectrum HPV Amplification and Detection System testing were carried out along with immunocytochemistry for CLDN1 and as a reference using CINtec p16 Cytology Kit Three different evaluation protocols were used which assessed immunostaining characteristics with or without cytological readings High correlation observable between p16INK4a and CLDN1 established CLDN1 as a competing marker in cervical cancer Concordance of CLDN1 immunostaining of cervical intraepithelial neoplasia 2 and above CIN2+ positives was 840  738–893 concordance of CIN2+ negatives was 690  596–758 In conclusion CLDN1 has similar diagnostic potential as p16INK4a our results established it as a histological and cytological biomarker with the potential to improve the clinical performance of cervical cytology and histologyThis work was supported by FP7 Collaborative project Automatic Cancer Screening Based on Realtime PCR – AUTOCAST HEALTH20072414 NKFP 07 2SPESAFE Jedlik Ányos 2nd sub program KMR 12120120032 by the Hungarian National Research and Development Fund and by the Hungarian National Research Foundation PD105019

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