Hospital-based Validation of the New ELEVATE Screening Tool

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.

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. This point-of-care test is a portable, battery-powered device compatible with self-sampling and comprises a Human Papillomavirus (HPV) DNA test as well as a proteomic biomarkers detection sensor, aiming for high sensitivity and specificity. The test can be offered in a broad range of settings and results are available in less than 24 hours, eliminating the need for sample storage and lab infrastructure. 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. The self-sample will be taken by using the Evalyn brush (Rovers - CE-approved device), while the endocervical sample will be taken by the gynaecologist with a standard endocervical brush used in the hospital. Both sampling measures are considered non-invasive. The ELEVATE screening tool is composed out of a device and cartridges. The ELEVATE cartridge is a microfluidic cartridge, consisting of the 2 sensor types (genomic and proteomic), onto which cervical fluid will be brought drop by drop. This cartridge will then be introduced into the ELEVATE screening device, after which via electrochemical signals the HPV DNA and protein result will become clear. The new ELEVATE screening test (or tool) is an HPV DNA detection and protein detection test under development; results based on the new test will not be shared with the patient or health care provider. Results of the tool will be compared with standard laboratory tests. Only the result of the standard laboratory tests will be fed back to the patient if requested by the patient (as also mentioned in the ICF).

The following tests will be performed at UZ Gent:

* new ELEVATE screening test (HPV DNA detection and protein detection) on self-sample and endocervical samples from women from Belgium (100 women, 200 samples)
* Standard lab test HPV DNA Detection: AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test; on all samples, including samples sent to Belgium from the women from Ecuador (200 women, 400 samples)
* Standard lab test protein detection: ELISA protein detection: only available comparison test; on all samples, inlcuding samples sent to Belgium from the women from Ecuador (200 women, 400 samples)

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
* new ELEVATE screening test (HPV DNA detection and protein detection) on self-test and endocervical sample from women from Ecuador (100 women, 200 samples)

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.

Eligibility Criteria:
Inclusion Criteria:

* have a previous abnormal pap smear/recent diagnosis of cervical dysplasia (\<4 months) and therefore have a colposcopy appointment, or
* a positive HPV test (\<4 months) and therefore have a colposcopy appointment, and
* able to understand the study materials (questionnaire) and informed consent form

Exclusion Criteria:

* women with heavy bleeding at consultation
* women with known pregnancy at consultation
* women who are undergoing or have completed chemotherapy in the six months prior to the enrollment, or received LEEP, cryotherapy or another treatment in the six months prior to enrollment
* women who do not consent