Hospital-based Validation of the New ELEVATE Screening Tool

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Cervical CancerHPV Infection
Interventions
BEHAVIORAL

Questionnaire

Questionnaire to probe socio-demographic data and information regarding sexual and reproductive health.

PROCEDURE

HPV self-sample

Collection of HPV self-sample. The study nurse will explain step by step how the participant should take the test. The participant will also be given written instructions and the study nurse will always be around if the participant has any questions. The participant will be asked to take the self-sample in a private room with toilet. After collection the sample is handed back to the study nurse, who will then take the samples to the laboratory for analysis.

PROCEDURE

Endocervical sample

Endocervical sample taken by the gynaecologist. This procedure can be somewhat uncomfortable but not painful. The participant may always ask questions if she has any doubts or questions. The gynaecologist will perform the standard colposcopy examination after collection (for which the woman sits in the colposcopy waiting room)

Trial Locations (2)

9000

Ghent University Hospital, Ghent

Unknown

SOLCA University Hospital, Cuenca

All Listed Sponsors
collaborator

Horizon 2020 - European Commission

OTHER

collaborator

Universidad de Cuenca

OTHER

lead

University Hospital, Ghent

OTHER