Registry Study of the Working Group on Cervical Pathology and Colposcopy (AGCPC) on the Diagnostic Algorithm for the New Cervical Cancer Screening - Persistent HPV Infections and Squamous Cell Lesions: Evaluation of over 10000 Patients.

Introduction: Cervical cancer screening in Germany was newly regulated as of January 1, 2020. Since then, an organized cancer screening guideline (oKFE-RL) for cervical cancer screening has been effective. From the age of 20, a cytological smear is taken once a year and from the age of 35 a co-test is carried out every three years. In the event of abnormalities, an algorithm regulates the procedure. This algorithm states that even so-called low-risk groups should have a diagnostic colposcopy at an early stage. This approach has been widely discussed and continues to serve as the basis of this registry study. Methods: All patients who presented for a diagnostic colposcopy to the respective participating centers were included after consent. The focus was on the detection rate of CIN 3+ in diagnoses related to squamous cell changes and persistent HPV infection. The current data were compared with previous results to obtain information about the development of the new screening program. Results: A total of 12311 patients were included. The referral diagnosis was normal cytology and persistent HPV infection in 30.7%, normal cytology but positive case history and persistent HPV infection in 2.6%, and ASC-US in 11.0%. 7.7% had a cytological diagnosis of ASC-H and 17.6% had LSIL. 16.3% had HSIL (moderate dysplasia), 9.2% had HSIL (severe dysplasia) and 0.3% had HSIL with features suspicious for invasion. Cytology-diagnosed squamous cell carcinoma was found 0.2%. CIN 3+ was found in 63.3% of cases with HSIL (severe dysplasia). 27.4% of the HSIL group (moderate dysplasia) were diagnosed as CIN 3+ and 27.6% of the ASC-H group as CIN 3+ but with a relatively high percentage of cervical carcinomas (n = 7). CIN 3+ was identified in 10.7% of the LSIL group and in 10.8% of the ASC-US group. In the groups with persistent HPV infection/normal cytology (with or without a positive case history), 7.1/6.3% were diagnosed as CIN 3+ and 12.8% of HPV-negative patients as CIN 3+. When groups were differentiated according to age into "below the age of 35" and "35 years and above", only the younger group of HPV-negative patients had a statistically significantly higher rate of CIN 3+. Discussion: Using these data, we were able to show that, with the exception of the group with persistent HPV infection/normal cytology (without or with a positive case history), the target lesion CIN 3+ was identified in over 10% of cases. We suggest that a reevaluation to take high-risk HPV types into consideration should be carried out as some HPV types are associated with a significantly higher risk of developing cervical cancer and its precursors than other types. It is too early to say whether the new screening program will reduce the incidence and mortality of cervical cancer; this will need to be checked in further evaluations.