Hospital-based Validation of the New ELEVATE Screening Tool

NCT06304610 | Not Yet Recruiting

• 1 other identifier: ONZ-2024-0044
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

cervical cancer; screening; self-sampling; HPV; underscreened; new ELEVATE tool

Outcome Measures

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).

  Up to 8 months

Secondary Outcomes (3)

• Concordance

  Up to 8 months

• HPV DNA test validation

  Up to 8 months

• Protein test validation

  Up to 8 months

Study Arms (1)

Sample taking and questionnaire

EXPERIMENTAL

The participant is invited in the colposcopy waiting room by the study nurse and is asked to follow the study nurse to a separate room. Here the participant is given all the information about the study and sampling. If the participant agrees to participate and signs the consent form, the study nurse registers the participant and then asks her to complete a very short questionnaire. After that, the participant will be asked to take a self-sample. Then the participant will proceed to her appointment for colposcopy. The doctor will take an endocervical samples, similar to a pap smear, before the actual colposcopy examination begins. Her samples will then be analyzed with the newly developed ELEVATE test and with comparative lab tests (standard HPV DNA detection and protein detection tests) in order to validate the newly developed ELEVATE cervical cancer screening test. Participation is free and the participant can stop your participation at any time.

Behavioral: Questionnaire; Procedure: HPV self-sample; Procedure: Endocervical sample

Interventions

Questionnaire BEHAVIORAL

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

Sample taking and questionnaire

HPV self-sample PROCEDURE

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.

Sample taking and questionnaire

Endocervical sample PROCEDURE

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)

Sample taking and questionnaire

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Horizon 2020 - European Commission: collaborator
• Universidad de Cuenca: collaborator

Study Sites (2)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

SOLCA University Hospital

Cuenca, Ecuador

Location

Related Links

• Related Info

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olivier Degomme, MD,PhD,Prof

  International Centre of Reproductive Health

  STUDY CHAIR

• Philippe Tummers, MD,PhD,Prof

  Vrouwenkliniek, UZ Ghent

  PRINCIPAL INVESTIGATOR

• Bernardo José Vega Crespo, MD

  Universidad de Cuenca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heleen Vermandere, PhD

CONTACT

+32-9-332.35.64; heleen.vermandere@ugent.be

Marie Hendrickx, MSC

CONTACT

+32-9-332.35.64; marie.hendrickx@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all participants receive the same tests

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BE (1); EC (1)