Ane-Kersti Skaarup Knudsen

Assessment of a colposcopic scoring system (Swedescore) to reduce the number of cervical biopsies: a protocol for a clinical multicentre non-randomised intervention study in Denmark

Introduction Colposcopy is a standard procedure for evaluating cervical abnormalities and collecting cervical biopsies. The procedure is associated with intra- and inter-observer variation. A colposcopic scoring system, Swedescore, has been designed to standardise and facilitate colposcopy training. Swedescore has performed well in a routine clinical setting when used by expert colposcopists to find or exclude high-grade lesions. Danish clinical guidelines for colposcopy differ from other countries, as they recommend collecting four cervical biopsies in all women regardless of risk factors or colposcopy findings. Swedescore has never been examined to assess the reduction of cervical biopsies in a real-world clinical setting. This study aims to investigate whether the implementation of Swedescore can optimise the diagnostic work-up for whom the collection of biopsies can be safely omitted or reduced. Methods and analysis The design is a clinical multicentre non-randomised intervention study in Denmark. According to a power calculation, we will need to include 586 women referred for colposcopy. Colposcopy with Swedescore will be compared with conventional colposcopy with no Swedescore. Cervical biopsies will be divided into two separate vials (target and random biopsies). The primary outcome will be normal or cervical intraepithelial neoplasia grade 1 detected in cervical biopsies. χ 2 and logistic regression will be used to compare estimates between arms. Ethics and dissemination The study protocol has been submitted to the Ethical Committee in Central Denmark region and is not notifiable to the Committee (j.no.: 1-10-72-124-22). Results will be published in a peer-reviewed journal and presented at scientific meetings. Trial registration number NCT05870787 . Protocol version Version 3 (date 12. November 2024).

Negative margins and negative HPV tests after large loop excision of the transformation zone: A nationwide historical cohort study

Abstract Introduction Adequate treatment of cervical precancer, defined as negative margins and a negative HPV test post‐treatment, is essential for cervical cancer prevention, as inadequate excision of cervical precancer and a positive HPV test are associated with increased risk of recurrence. Here, we aimed to describe trends in the proportion of women receiving adequate treatment in Denmark. Material and Methods Nationwide historical cohort study including Danish women ≥18 years treated with large loop excision of the transformation zone (LLETZ) from 2013 to 2022. Using the Danish Pathology Register, we collected information on all LLETZ procedures performed due to cervical intraepithelial neoplasia grade 1 or worse (CIN1+). We calculated the proportion of negative margins and negative HPV tests post‐treatment, overall and stratified by histology, age, calendar time, and residing region. Results were mainly reported descriptively. Results We included 41 128 women (median age: 35 years, interquartile range: 28–44). A total of 20 744 (50.4%) had negative margins, with the lowest proportion in women with CIN3 (47.2%) or adenocarcinoma in situ (38.3%). The proportion of negative margins declined with increasing age, from 54.1% in women aged 18–29 years to 43.6% in women aged ≥50 years. Overall, 62.4% had a negative HPV test, with no major differences observed across histology groups. The proportion of negative HPV tests ranged from 62.8% to 66.9% in women aged 18–49, whereas it was lower in women aged ≥50 years (48.4%). Conclusions Women aged ≥50 years were less likely to have negative margins and a negative HPV test post‐treatment compared to women aged 18–49. These findings prompt a need to optimize treatment in this group of women to reduce the risk of cervical cancer.

iMproving thE DIagnostics And Treatment Of ceRvical Precancer

Cervical cancer screening is important as it enables identification of women at increased risk of the disease, but high-quality diagnostics of screen-positive women and effective treatment of those with precancer are critical in preventing progression to cancer. With the current transition from cytology-based to primary human papillomavirus (HPV)-screening and a growing proportion of HPV-vaccinated women, diagnostics of screen-positive women will become more challenging in the decades to come. Thus, there is a need to explore how to improve diagnostics while ensuring a low number of unnecessary procedures such as colposcopy and the collection of multiple cervical biopsies. The overall purposes are: Purpose 1: To investigate the diagnostic accuracy of cervical precancer when using a colposcopic scoring system in the diagnostic work-up of screen-positive women. Purpose 2: To investigate the performance of a colposcopic scoring system to identify women without cervical precancer in whom collection of biopsies can be safely omitted.