protocolSection identificationModule nctId: NCT06304610, orgStudyIdInfo id: ONZ-2024-0044, briefTitle: Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador, acronym: ELEVATE-Pilot, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, collaborators name: Horizon 2020 - European Commission, collaborators name: Universidad de Cuenca, descriptionModule briefSummary: 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 testIn 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 testConcordance 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., conditionsModule conditions: Cervical Cancer, conditions: HPV Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: all participants receive the same tests, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, interventions name: HPV self-sample, interventions name: Endocervical sample, outcomesModule primaryOutcomes measure: Clinical validation, secondaryOutcomes measure: Concordance, secondaryOutcomes measure: HPV DNA test validation, secondaryOutcomes measure: Protein test validation, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ghent University Hospital, city: Ghent, state: East-Flanders, zip: 9000, country: Belgium, contacts name: Steven Weyers, MD,PhD,Prof, role: CONTACT, phone: 09 332 37 83, email: steven.weyers@uzgent.be, contacts name: Philippe Tummers, MD,PhD,Prof, role: CONTACT, phone: 09 332 37 83, email: philippe.tummers@uzgent.be, contacts name: Philippe Tummers, MD,PhD,Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Heleen Vermandere, PhD, role: SUB_INVESTIGATOR, contacts name: Marie Hendrickx, MSC, role: SUB_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: SOLCA University Hospital, city: Cuenca, country: Ecuador, contacts name: Bernardo José Vega Crespo, role: CONTACT, phone: 0998276441, email: bernardo.vegac@ucuenca.edu.ec, contacts name: Bernardo José Vega Crespo, role: PRINCIPAL_INVESTIGATOR, contacts name: Dayanara Delgado, role: SUB_INVESTIGATOR, contacts name: Vivian Alejandra Neira Molina, role: SUB_INVESTIGATOR, geoPoint lat: -2.90055, lon: -79.00453, hasResults: False