Article Text

Download PDFPDF
573 Surveillance of cervical intraepithelial neoplasia grade 2 with dual P16/Ki-67 immunocytochemistry staining. preliminary results of the CIN2DIN study
  1. Kimon Chatzistamatiou1,
  2. Vasilis Theodoulidis1,
  3. Dimitrios Zouzoulas1,
  4. Lambros Kambas2,
  5. Spiridon Gerou2,
  6. Theodoros Moysiadis3,
  7. Panagiotis Tzitzis1,
  8. Kalliopi Kissoudi1,
  9. Nikos Roussos1,
  10. Eleni Mpili1,
  11. Themistoklis Mikos1,
  12. Grigoris Grimbizis1 and
  13. Dimitrios Tsolakidis1
  1. 11st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Thessaloniki, Greece
  2. 2Diagnostic Research Laboratory Analysi, Thessaloniki, Greece
  3. 3Department of Computer Science, School of Sciences and Engineering, University of Nicosia, Nicosia, Cyprus


Introduction/Background Excisional cervical procedures have been linked to an increased risk of preterm birth. Therefore, efforts are being made to avoid surgical treatment, for women with cervical intraepithelial neoplasia (CIN) grade 2, a condition with high regression rates. The CIN2DIN study aims to determine the diagnostic accuracy of P16/Ki-67-immunocytochemistry (ICC) for the surveillance of untreated CIN2, compared to cytology.

Methodology Women with biopsy confirmed CIN2, after written informed consent, are 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 are subjected to colposcopy, and, cervicovaginal sampling for cytology and p16/Ki-67-ICC. After 12 months (t=2) participants are subjected to colposcopy, and cervicovaginal sampling for hrHPV testing, cytology and p16/Ki-67-ICC. Participants are 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. Registered-protocol: ISRCTN56383373.

Results Twenty-two women with CIN2 have been recruited; results are available for 12/20. Four women exited the study (3 with a negative cobas HPV test at baseline; one with CIN3 after pathology review). Nine women tested positive for hrHPV (non-16/18); of those 1 woman had a positive CINtec test, and 6 had an ASCUS or worse. One woman tested positive for HPV16, and for CINtec, and had HGSIL cytology. Two women tested positive for HPV16 and hrHPV (non-18); of those one had positive CINtec, and HGSIL cytology, and the other had negative CINtec and ASCH.

Conclusion Among women with CIN2 the rate of a positive CINTEC+ test is lower than that of cytology testing, possibly reflecting a difference in the oncogenic potential of CIN2 cases.

Disclosures No conflict of interest.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.