Table 1.

Overview and main characteristics of the study

Study registration number	ClinicalTrials.gov NCT05049252
Location	Aarhus University Hospital, Central Denmark Region, Denmark
Study affiliation	Department of Gynecology and Obstetrics, NIDO - Center for Research and Education, Gødstrup Hospital, DK Department of Clinical Medicine, Aarhus University, DK Department of Pathology, Aarhus University Hospital, DK
Design	Historical cohort
Study period	2020–2023
Time of CIN2 diagnosis	2000–2010
Study population	N=500, women 23–40 years of age with an incidental CIN2 diagnosis, managed by active surveillance (2 years)
Database	The Danish Pathology Databank
Primary SNOMED codes	M74B09, T83110
Biomarkers	SILgrade-E4 8XR-E4-1 (2 ug/mL); p16INK4a (CINTec, (antibody clone E6H4))
Laboratory methods	Immunohistochemical staining (Ventana, BenchMark ULTRA, Roche Diagnostics)
Exposure	Positive HPV E4 intraepithelial expression
Outcome	Regression defined as CIN1 or less
Main variables considered in the statistical analysis	Number of cervical punch biopsies collected at the time of index CIN2 community diagnosis. Number of follow-up visits during active surveillance. Age will be considered in an ancillary analysis Cervix cytology status at index CIN2 diagnosis in an ancillary analysis

CIN, cervical intraepithelial neoplasia; HPV E4, Human papillomavirus E4 immunohistochemical biomarker; SNOMED, Systematized Nomenclature of Medicine.