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Uterine Cervical Neoplasms

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Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Disease Attributes

A community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. Women will be informed about cervical cancer screening (pap smear) and about where they can obtain these services off-site (health facilities). Furthermore, a self-administrated questionnaire is applied to assess current knowledge, willingness to get screened (clinically collected sample) and uptake

A community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. In addition, women will receive information about self-sampling and will be instructed by the community-based researcher on how to take a self-sample using an illustrative cartoon. Women will then be invited to take a sample on-site. The researcher will collect all samples for analysis by an HPV test in a lab. Sample analysis is expected to take 2 weeks time.

A community-based researcher will educate women about sexual health and cervical cancer by using the materials that will be developed by the ELEVATE team. Women will be informed about cervical cancer screening (pap smear) and about where they can obtain these services off-site (health facilities). Furthermore, a self-administrated questionnaire is applied to assess current knowledge, willingness to get screened (clinically collected sample) and uptake.

Educational session

Women will receive information about self-sampling and will be instructed by the community-based researcher on how to take a self-sample using an illustrative cartoon. Women will then be invited to take a sample on-site, to measure the uptake of the self-sampling test (% of women who take the self-sample). Furthermore, two self-administrated questionnaires are applied to 1) assess attitudes regarding self-sampling (pre-intervention), and 2) assess users' experience regarding self-sampling (post-intervention). The researcher will collect all samples for analysis by an HPV test in a lab. Sample analysis is expected to take 2 weeks time. All women will be contacted 1-2 weeks after the self-sample taking to inform them on their test result.

Self-sampling

To gauge the knowledge on cervical cancer screening after the educational session and to verify whether they got a pap smear, a 3-month follow-up is proposed for all women receiving an educational session (arm 1) and all women receiving an educational session and a self-sample (arm 2), because all women, whether or not invited for self-sampling, are provided information on where to get screened, although there is no formal referral to screening services.

Follow-up assessment

Heleen Vermandere, PhD

Marie Hendrickx, MSC

Adhemar Longatto Filho

Priscila Grecca Pedrão

Anna Karolina da Silva Oliveira

Ricardo dos Reis

Rui Manuel Reis

Sónia Dias

Ana Gama

Bernardo Vega Crespo

Adhemar Longatto

Olivier Degomme

This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).

ELEVATE, a five-year project conducted by an international research alliance led by Ghent University, aims to develop a new test and approach for cervical cancer screening in hard-to-reach populations. The test will combine self-sampling with a new low-cost, portable measurement device and will be validated in dedicated screening trials in Belgium, Brazil, Ecuador, and Portugal. The ELEVATE project targets women in Europe and Latin America who have never been screened or are not regularly screened. These women have a higher risk of developing cervical cancer. The project is supported by the European Union's Horizon 2020 Framework Programme for Research and Innovation Action, project number 825747.

To address the gaps in cervical cancer screening, the ELEVATE project is developing a screening strategy to make cervical screening more accessible to hard-to-reach women. This strategy will include the introduction of a new on-site HPV self-sampling screening tool and a portable testing device, able to detect the presence of HPV and cancer biomarker proteins. This portable, low-cost, on-site HPV testing tool will allow to streamline follow-up care for women at risk of developing cervical cancer.

This study is part of the ELEVATE project and takes place in hard-to-reach communities, focusing on socio-economically vulnerable women to assess the acceptability of educational sessions and self-sampling in these communities. This study includes a two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).

ELEVATE Acceptability Study

EarLy dEtection of cerVical cAncer in Hard-to-reach Populations of Women Through Portable and Point-of-care HPV TEsting Acceptability Study

Compare the on-site uptake of self-sampling (arm2) with uptake of standard care (follow-up of arm1)

Attitudes towards self-sampling: reasons to accept/decline the self-sample; advantages and disadvantages versus conventional screening.

User experiences among those who took a self-sample (easy/difficult; painless/painfull; trustworthy/untrusty; etc.)

Horizon 2020 - European Commission

Universidade Nova de Lisboa

Universidad de Cuenca

Hospital de Cancer de Barretos - Fundacao Pio XII

University Ghent

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.

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

Questionnaire

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.

HPV self-sample

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)

Endocervical sample

Steven Weyers, MD,PhD,Prof

Philippe Tummers, MD,PhD,Prof

Bernardo José Vega Crespo

Dayanara Delgado

Vivian Alejandra Neira Molina

Olivier Degomme, MD,PhD,Prof

Bernardo José Vega Crespo, MD

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.

Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador

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).

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).

To determine the sensitivity and specificity of the HPV DNA test of the ELEVATE screening test according to clinically relevant outcomes

To determine the sensitivity and specificity of the protein test of the ELEVATE screening test according to clinically relevant outcomes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ELEVATE Acceptability Study	NCT06136702	Cervical Cancer HPV Infection Acceptability o...	Educational ses... Self-sampling Follow-up asses...	25 Years - 65 Years	University Ghent
Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador	NCT06304610	Cervical Cancer HPV Infection	Questionnaire HPV self-sample Endocervical sa...	30 Years - 65 Years	University Hospital, Ghent
Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador	NCT06304610	Cervical Cancer HPV Infection	Questionnaire HPV self-sample Endocervical sa...	30 Years - 65 Years	University Hospital, Ghent

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