Hospital-based Validation of the New ELEVATE Screening Tool

Summary

ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations.

In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer.

At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests.

Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador):

* AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test
* ELISA protein detection: only available comparison test

In order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium):

• HPV DNA Mole Bioscience test

Concordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes.

Conditions

• Cervical Cancer
• HPV 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)

Sponsors & Collaborators

• Horizon 2020 - European Commission

  collaborator OTHER

• Universidad de Cuenca

  collaborator OTHER

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Olivier Degomme, MD,PhD,Prof · International Centre of Reproductive Health

• Philippe Tummers, MD,PhD,Prof · Vrouwenkliniek, UZ Ghent

• Bernardo José Vega Crespo, MD · Universidad de Cuenca

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Belgium
• Ecuador

Study Locations