Claudin-1 as a Biomarker of Cervical Cytology and Histology

Márta Benczik, Ádám Galamb, Róbert Koiss, Attila Kovács, Balázs Járay, Tamás Székely, Tímea Szekerczés, Z. Schaff, G. Sobel, Csaba Jeney

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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 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 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.

Original languageEnglish
Pages (from-to)179-188
Number of pages10
JournalPathology and Oncology Research
Issue number1
Publication statusPublished - Jan 1 2016



  • Biomarker
  • Cervical cancer
  • Claudin-1
  • Immunocytochemistry

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pathology and Forensic Medicine

Cite this

Benczik, M., Galamb, Á., Koiss, R., Kovács, A., Járay, B., Székely, T., Szekerczés, T., Schaff, Z., Sobel, G., & Jeney, C. (2016). Claudin-1 as a Biomarker of Cervical Cytology and Histology. Pathology and Oncology Research, 22(1), 179-188.