Registry Study of the Working Group on Cervical Pathology and Colposcopy (AGCPC) on the Diagnostic Algorithm for the New Cervical Cancer Screening – Initial Data
Authors: Henes Melanie , Mann Ellen , Hirchenhain Christine , Bauer Emanuel , Kentner Alexander , Quaas Jens , Koßagk Christopher , Gallwas Julia , Henes Leon , Schumacher Antonia , Küppers Volkmar 
Published: October 2023

For the first time since 1971, new regulations were introduced for cervical cancer
screening as an organized cancer screening guideline (oKFE-RL) starting 1 January 2020. From
the age of 20, a cytological smear test is performed annually, and from the age of 35,
so-called co-testing (cytology and test for high-risk HPVs) is performed every three years.
In case of abnormalities, the algorithm is used as the basis for investigation. According to
this diagnostic algorithm, even so-called low-risk groups receive early colposcopic
evaluation. This approach has been heavily debated and serves as the basis for this registry
study.

All patients who presented to the centers for a colposcopy as part of the diagnostic
algorithm were included after signing an informed consent form. The following findings were
obtained: Medical history, colposcopy, histology, and cytology findings, as well as possible
therapies and their findings. The aim was to evaluate the frequency of the target lesions
cervical intraepithelial neoplasia (CIN) 2+/CIN 3+ in the respective groups.

A total of 4763 patients were enrolled in the study from July 2020 to October 2022. As a
referral diagnosis, HPV persistence (HPV: human papillomavirus) with group I was determined
in 23.9% (1139), HPV persistence with group II-a in 2.1% (100), II-p (ASC-US) in 11.2%
(535), and II-g (AGC endocervical NOS) in 1.3% (64). III-p (ASC-H) and III-g (AGC
endocervical favor neoplastic) were found in 9.4% (447) and 2.2% (107), respectively, IIID1
(LSIL) in 19% (906), IIID2 (HSIL, moderate dysplasia) in 18.9% (898), IVa-p (HSIL, severe
dysplasia) in 10.7% (508), IVa-g (AIS) in 0.7% (31), IVb-p (HSIL with features suspicious
for invasion) and IVb-g (AIS with features suspicious for invasion) in 0.3% (15), 0.1% (6),
and 7 with suspected invasion V-p (squamous cell carcinoma)/V-g (endocervical
adenocarcinoma) (0.1%). In the IVa-p group (HSIL, severe dysplasia), 67.7% had CIN 2+ and
56.5% had CIN 3+, adenocarcinoma in situ (AIS), and adenocarcinoma. If the histology of the
excised tissue specifically based on the colposcope findings was also evaluated, CIN 2+ was
found in 79.7% of cases, and CIN 3+ in 67.3% of cases. In IIID2 (HSIL, moderate dysplasia),
CIN 2+ was detected in 50.9%, and CIN 3+/AIS in 28.3%. After evaluating patients who
underwent surgery immediately, this increased to 53.0% for CIN 2+ and 29.3% for CIN 3+/AIS.
In IIID1 (LSIL), CIN 2+ was detected in 27.4% and CIN 3+/AIS in 11.7%, and in II-p (ASC-US),
CIN 2+ was detected in 23.4% and CIN 3+ and AIS in 10.8%, and in II-g (AGC endocervical
NOS), CIN 2+ was detected in 34.4% and CIN 3+ in 23.4%. In the HPV persistence/II-a and I
group, 21% showed CIN 2+, and 12.1% showed CIN 3+ and AIS, and 13% showed CIN 2+ and 5.9%
showed CIN 3+ and AIS. In patients who were HPV-negative and had further diagnostics
performed on the basis of cytologic smear alone, 27.9% had CIN 2+, and 14.1% had CIN 3 and
AIS.

In a synopsis of the present findings of our initial data of the registry study on the
new cervical cancer screening, according to the organized early cancer screening guideline
(oKFE-RL), we could show that the target lesion CIN 3+ and AIS is detected unexpectedly
frequently in a not insignificant proportion, especially in the cytological low-risk group.
Currently, we cannot answer whether this can reduce the incidence and mortality of cervical
carcinoma, but this could be an initial indication of this and will be reviewed in further
long-term evaluations.