Project: COMPETE2030-FEDER-00910400- JANUS

Project name:	JANUS - Reengineering cervical cancer screening for the 21st century: joint action for a novel up-to-date and sustainable screening program
Project code:	COMPETE2030-FEDER-00910400- JANUS
Intervention Region:	Norte
Proposing institution/Lead promoter/Coordinating entity:	Instituto de Saúde Pública da Universidade do Porto
Partner(s)/Co-promoter(s)/Participating institution(s):	Faculdade de Medicina da Universidade do Porto; Instituto Português de Oncologia do Porto; Unidade Local de Saúde de Gaia e Espinho, E.P.E.
Start date:	2025-01-01
Completion date:	2027-12-31

Objectives, activities and expected/achieved results

The primary objectives are:
1) To compare the adherence to CCS based on self-sampling (for HrHPV testing) with screening based on sampling for liquid-based cytology (LBC)-based HPV testing performed by a health professional (the current standard of care), in a non-inferiority framework of analysis;
2) To compare the adherence to CCS based on self-sampling, followed by LBC-based HPV testing for the non-adherent to self-sampling, with the current standard of care, in a superiority framework of analysis;
3) To compare the adherence to CCS based on self-sampling, followed by LBC-based HPV testing for the non-adherent to self-sampling, with the current standard of care followed by self-sampling for the non-adherent to the standard of care, in a non-inferiority framework of analysis;
4) To assess biomarker performance of DNA methylation markers for high-grade squamous intraepithelial lesions or worse (HSIL+) detection, in different contexts of population-based CCS, involving self-sampling and LBC HPV testing performed by a health professional, used alone or sequentially.
Secondary objectives include stratifi ed analyses in sub-groups of the population defi ned according to age, deprivation index of the place of residence, CCS history and organization model of the primary healthcare units.This study uses a randomized design for assessing the effect of using self-sampling instead of the standard of care, but also the effect of two alternative options for the sequential incorporation of self-sampling in the screening process, namely self-sampling as the primary option, complemented (among women non-adherent to self-sampling) by collection of the sample by a health professional, versus the standard of care, complemented (among women non-adherent) by self-sampling. Furthermore, the assessment of performance of methylation markers will determine whether a full molecular flow may be feasible, enabling the exclusive use of self-collected samples and precluding the need for a subsequent LBC collection in HrHPV positive cases identifi ed in self-collected samples.

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