A study about the efficiency of cervical cancer screening using biomarkers p16/Ki67 and claudin 1

Introduction: Cervical cancer screening lowered the incidence of cervical malignant tumours in developing countries. However, the current screening techniques lack a high rate in sensitivity and specificity. New methods have been developed in order to raise the susceptibility of screening, marking the presence of E6/E7 HPV oncoproteins and the distinct intracellular lesions that occur during HPV infection, more precisely the presence of p16 and claudin 1. These biomarkers could be used as a diagnostical criteria. Objective: Our objective was to highlight the efficacy of p16/Ki67 and claudin 1 tumor markers in addition to traditional oncocitology, and to reevaluate clinical management in Hungary using these techniques. Material and methods: 792 Liquid based citologies were collected in the 2nd Gynaecology Department of Semmelweis University Budapest that were analyzed in the 2nd Pathology Department of the University. Out of these samples 694 were tested with PCR for the presence of High Risk and Low Risk Human Papillomavirus. Using CINTech Plus Kit 209 samples were tested for p16/Ki67 presence and claudin 1/Ki67 was tested for 80 patients. Collecting these several data from patients and comparing them with histological findings we tried to reevaluate the relevance of Pap citology and the current clinical management. Results: We succeeded to underline the efficiency of the new screening techniques, many of the Pap citologies being positive though not proved to be p16/Ki67 positive. 21,4% of citologies proved to belong to the, gray area”. Out of the 209 CINTech samples 42 were positive out of which 9.5% showed mild atypia (ASC-US) although incipient oncogenesis was present. 27 histologic samples were analyzed, 19 were CIN II–III. Out of these 2 had ASC-US citologies. 5 chronic cervicitis samples were in our database, 4 being CINTech negative, but 2 had H-SIL citologies. Conclusion: The usage of new cervical screening techniques is highly needed in the present clinical care. P16/Ki67 and claudin 1 can minimize the number of unnecessary conizations, therefore can lead to a more cost efficient clinical care, not to mention post operative side effects and patient discomfort could be eliminated in many cases.