ACORN

The use of HPV genotyping in the management of cervical intraepithelial neoplasia in women with unsatisfactory colposcopy (ACORN Study)

 Summary

Large loop excision of the cervical transformation zone (LLETZ) removes a core of tissue and is the treatment of choice for cervical pre-cancer. Recent evidence however, has suggested that depth of excised tissue proportionally increases the risk of preterm labour. In women where the cells of interest are tucked inside the cervical canal (unsatisfactory colposcopy), assessment of who can be safely followed up is problematic. A LLETZ is undertaken and in approximately 18% of women no lesion is found. Although reassurance has been obtained, it is at the cost of an unnecessary invasive procedure.

Studies have shown that testing for different strains of a virus known to cause cervical cancer (Human Papillomavirus) may improve assessment of who needs treatment. We propose to use this test on previously taken smear samples, so that no new samples will be taken, and compare the results to the LLETZ histology already completed as part of routine care. This is therefore a diagnostic feasibility study to assess whether HPV genotyping can improve diagnostic accuracy, decrease patient morbidity and improve clinical efficiency and cost effectiveness. Results from this pump-priming study will provide a confidence interval and power calculation for a definitive portfolio randomised control trial.

 Publications

Manley KM, Wills AK, Villeneuve N, Hunt K, Patel A, Glew S. Comparison of the Cervex-Brush alone to Cytobrush plus Cervex-Brush for detection of cervical dysplasia in women with a transformation zone type 3. Cytopathology. 2019 Mar;30(2):157-163. doi: 10.1111/cyt.12647. Epub 2018 Dec 21. PMID: 30414286.

Manley, K., Patel, A., Pawade, J.  et al. The use of biomarkers and HPV genotyping to improve diagnostic accuracy in women with a transformation zone type 3. Br J Cancer 126,  91-99 (2022). https://doi.org/10.1038/s41416-021-01539-y

Poster:

British Society for Colposcopy and Cervical Pathology (bsccp), April 2021: Managing Patients with Type III TZs Dr Kristyn Manley, University Hospitals Bristol, UK