Hospital-based Validation of the New ELEVATE Screening Tool
Launched by UNIVERSITY HOSPITAL, GHENT · Mar 4, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The ELEVATE clinical trial is studying a new screening test for cervical cancer, which is especially important for women who might have trouble accessing regular healthcare. This project, led by researchers from Ghent University, aims to better detect cervical cancer and HPV (the virus that can lead to cancer) by using self-collected samples and other tests. They will recruit 200 women aged 30 to 65 who have had recent abnormal pap smear results in Belgium and Ecuador. Participants will provide both a self-sample and a sample collected by a healthcare provider before undergoing a routine examination.
To be eligible, women need to have a recent abnormal pap smear or a positive HPV test and must have a scheduled appointment for a follow-up examination (colposcopy). Women who are pregnant, experiencing heavy bleeding, or who have received certain treatments in the last six months cannot participate. During the trial, participants will fill out a short questionnaire and provide their samples, which will then be tested both with the new ELEVATE screening tool and standard tests to compare results. This research could lead to better cervical cancer screening methods, making it easier for women to get the care they need.
Gender
FEMALE
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
About University Hospital, Ghent
University Hospital Ghent is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. Located in Ghent, Belgium, the hospital is affiliated with Ghent University, fostering a collaborative environment that integrates cutting-edge medical research with high-quality patient care. With a diverse range of specialized departments and a dedicated team of researchers and clinicians, University Hospital Ghent is at the forefront of developing new therapies and improving treatment protocols, aiming to enhance patient outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ghent, East Flanders, Belgium
Cuenca, , Ecuador
Patients applied
Trial Officials
Olivier Degomme, MD,PhD,Prof
Study Chair
International Centre of Reproductive Health
Philippe Tummers, MD,PhD,Prof
Principal Investigator
Vrouwenkliniek, UZ Ghent
Bernardo José Vega Crespo, MD
Principal Investigator
Universidad de Cuenca
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported