Hospital-based Validation of the New ELEVATE Screening Tool
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Questionnaire
BehavioralQuestionnaire to probe socio-demographic data and information regarding sexual and reproductive health.
HPV self-sample
Procedure/SurgeryCollection 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.
Endocervical sample
Procedure/SurgeryEndocervical 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)
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Sample taking and questionnaireExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Clinical validation
To determine the sensitivity and specificity of the new ELEVATE screening test, combining HPV DNA detection and biomarker detection, according to clinically relevant outcomes (coloscopy results).
Time frame
Up to 8 monthsSecondary outcomes
1
Concordance
To determine the concordance between the test results of the new ELEVATE screening test and standard tests on the self-sample and endocervical sample (for both HPV DNA and protein detection).
Time frame
Up to 8 months2
HPV DNA test validation
To determine the sensitivity and specificity of the HPV DNA test of the ELEVATE screening test according to clinically relevant outcomes
Time frame
Up to 8 months3
Protein test validation
To determine the sensitivity and specificity of the protein test of the ELEVATE screening test according to clinically relevant outcomes
Time frame
Up to 8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
Horizon 2020 - European Commission
Collaborator
Universidad de Cuenca
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: