Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

A Prospective Study on the Progression, Recurrence, and Regression of Cervical Lesions: Assessing Various Screening Approaches

Version 1 : Received: 20 February 2024 / Approved: 21 February 2024 / Online: 21 February 2024 (10:22:09 CET)

A peer-reviewed article of this Preprint also exists.

Gisca, T.; Munteanu, I.-V.; Vasilache, I.-A.; Melinte-Popescu, A.-S.; Volovat, S.; Scripcariu, I.-S.; Balan, R.-A.; Pavaleanu, I.; Socolov, R.; Carauleanu, A.; Vaduva, C.; Melinte-Popescu, M.; Adam, A.-M.; Adam, G.; Vicoveanu, P.; Socolov, D. A Prospective Study on the Progression, Recurrence, and Regression of Cervical Lesions: Assessing Various Screening Approaches. J. Clin. Med. 2024, 13, 1368. Gisca, T.; Munteanu, I.-V.; Vasilache, I.-A.; Melinte-Popescu, A.-S.; Volovat, S.; Scripcariu, I.-S.; Balan, R.-A.; Pavaleanu, I.; Socolov, R.; Carauleanu, A.; Vaduva, C.; Melinte-Popescu, M.; Adam, A.-M.; Adam, G.; Vicoveanu, P.; Socolov, D. A Prospective Study on the Progression, Recurrence, and Regression of Cervical Lesions: Assessing Various Screening Approaches. J. Clin. Med. 2024, 13, 1368.

Abstract

(1) Background: The prediction of cervical lesions evolution is a challenge for clinicians. The prospective study aimed to determine and compare the predictive accuracy of cytology, HPV genotyping, and p16/Ki67 dual staining alone or in combination with personal risk factors for the prediction of progression, regression or persistence of cervical lesions in human papillomavirus (HPV)-infected patients; (2) Methods: This prospective study included HPV-positive patients with or without cervical lesions that underwent follow-up. Descriptive statistics and sensitivity analysis for individual or combined index tests were used for data analysis; (3) Results: The highest predictive performance for the progression of cervical lesions was achieved by a model that comprised a Pap smear suggestive of high-grade squamous intraepithelial lesion (HSIL), the presence of 16/18 HPV strains, a positive p16/Ki67 dual staining result along with the presence of at least 3 clinical risk factors, which had a sensitivity (Se) of 74.42%, a specificity of 97.92%, an area under the receiver operating curve (AUC) of 0.961, and an accuracy of 90.65%. The prediction of cervical lesions regression or persistence was modest; (4) Conclusions: Multiple testing or new biomarkers should be used to improve HPV-positive patient surveillance, especially for cervical lesion regression or persistence prediction.

Keywords

cervical lesions; HPV genotyping; p16/Ki67 dual staining; cervical cytology; clinical risk factors.

Subject

Medicine and Pharmacology, Obstetrics and Gynaecology

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