title: Claudin-1 as a Biomarker of Cervical Cytology and Histology.
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. Claudin-1 (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 multi-centre clinical study in Hungary. Cytology and HPV (Genoid Full Spectrum HPVAmplification 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 84.0 % (73.8–89.3); concordance of CIN2+ negatives was 69.0 % (59.6–75.8). 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 histology.
authors.forename: Márta
authors.initials: M
authors.lastname: Benczik
authors.forename: Ádám
authors.initials: Á
authors.lastname: Galamb
authors.forename: Róbert
authors.initials: R
authors.lastname: Koiss
authors.forename: Attila
authors.initials: A
authors.lastname: Kovács
authors.forename: Balázs
authors.initials: B
authors.lastname: Járay
authors.forename: Tamás
authors.initials: T
authors.lastname: Székely
authors.forename: Tímea
authors.initials: T
authors.lastname: Szekerczés
authors.forename: Zsuzsa
authors.initials: Z
authors.lastname: Schaff
authors.forename: Gábor
authors.initials: G
authors.lastname: Sobel
authors.forename: Csaba
authors.initials: C
authors.lastname: Jeney
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism*; D016022:Case-Control Studies; D062445:Claudin-1 / Q000378:metabolism*; D003127:Colposcopy; D003581:Cytodiagnosis; D055088:Early Detection of Cancer; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006814:Hungary; D007124:Immunoenzyme Techniques; D060787:Neoplasm Grading; D018307:Neoplasms, Squamous Cell / Q000378:metabolism / Q000473:pathology* / Q000821:virology; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000378:metabolism / Q000473:pathology* / Q000821:virology; D011379:Prognosis; D002583:Uterine Cervical Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000378:metabolism / Q000473:pathology* / Q000821:virology
chemical_list: D014408:Biomarkers, Tumor; C568108:CLDN1 protein, human; D062445:Claudin-1