RISK-BASED SCREENING FOR CERVICAL CANCER

Periodic Reporting for period 1 - RISCC (RISK-BASED SCREENING FOR CERVICAL CANCER)

Okres sprawozdawczy: 2020-01-01 do 2021-06-30

Cervical cancer (CC) is the fourth most common cancer in women worldwide. Although CC is preventable through vaccination or detection in a precancerous state, in Europe alone in 2018, 61,000 new cases and 25,000 deaths have been reported. Many European countries have implemented organized CC screening and about 70 percent of the EU citizens have access to an organized program. The success is evident: in countries with an organized screening program, incidence and mortality rate have decreased up to 70 percent. Nevertheless, CC is still common and is even on the rise in several European countries. This underlines that if we want to eliminate CC as a public health problem, we need more effective screening.

Most screening programs report a high proportion of unnecessary colposcopy referrals (80 to >90 percent). The lack of efficiency is also reflected in the number of screening invitations which varies from 7 to >40 between European countries, but is not clearly associated with the country-specific CC incidence. This suggests considerable overconsumption in regions. This clearly underlines that we need more efficient screening. More effective and efficient screening go hand in hand and together they imply that screening resources should be directed to those most at risk. The effectiveness and efficiency of screening programs, which currently use one-size-fits-all protocols can be drastically improved by moving away from one-size-fits-all screening towards an approach based on individual risks. RISCC stands for “Risk-based Screening for Cervical Cancer” and aims to develop and evaluate the first risk-based screening program for CC, provide open-source implementation tools and contribute to the elimination of CC in Europe. An overview of objectives and their relations can be found in figure 1.

As part of WP1, a web-based management tool has been implemented on the RISCC website. Several meetings (all virtual) have occurred during the reporting period.

WP2 aims to develop CC risk profiles for screen-eligible women based on their screening history, separately for women using a self-sampling device or a physician-collected cervical sample. The data dictionary, data management plan and database (using an electronic data capture system) have been established. Next step is to upload data from all studies into the database.

WP3 aims to develop CC risk profiles for vaccinated cohorts. Two studies on risk-stratified screening are being performed in Finland, Study 1 in HPV vaccinated women and Study 2 in unvaccinated, indirectly protected women. Intermediate results (study 1) have indicated no difference in the incidence of high-grade squamous intraepithelial lesions among vaccinated women who were infrequently or frequently screened. Recruitment for study 2 is on track and is being conducted in 8 communities with herd effect protection and 8 control communities. In Italy, HPV prevalence and CIN2+ will be compared in a cohort of vaccinated and unvaccinated women.

WP4 will develop risk profiles including personal/patient-derived risk factors, based on the literature and by collecting data prospectively via surveys on the digital platform for risk-based screening. A comprehensive list of systematic reviews and meta-analyses that will be conducted as part of RISCC has been created. Besides, several systematic reviews and meta-analyses have already been completed, including a meta-analysis on the accuracy of tests that can be used to triage hrHPV positive women and a systematic review on the effect of offering self-sampling on screening attendance. Two new statistical packages (STATA) metadta and metapreg, for meta-analyses of diagnostic data and meta-regression of binomial data, respectively, were made publicly available.

WP5 will develop (cost-)effective risk-based screening algorithms. Coding has started for a prototype version of the open-source microsimulation model of oncogenic HPV progression to CC. The current version of the model has been optimized to reproduce a range of population-based CC screening algorithms as a function of age and vaccination status. We are in the process of adapting the model to account also for the screening history of each participant.

An open mobile (m-)health/e-health informatics platform that allows implementation of risk-based screening into real-life screening programs will be piloted and developed (WP6). A pilot feasibility study has been performed in Sweden and showed adherence to expected outcome. A full-scale study on risk-based screening for Swedish women at high risk of CC is now ongoing. The first version of the data model for the mobile platform has already been implemented in the beta version. In Belgium, 7 GP-practices agreed to participate in an evaluation study.

WP7 includes all dissemination and communication activities related to RISCC. An initial dissemination and communication plan has been created and agreed by all partners. The RISCC website is online and regularly updated. A free online course on CC screening has been developed, which targets European healthcare providers and management personnel willing to implement HPV-based screening. In June 2021, a Spanish version of the course was released at the Open University of Catalonia. The pilot edition will be continued to be worked on and by the end of 2021 the English version, as well as the Spanish one will be offered online for free. To engage women and ensure proper communication to laypeople, local ambassadors in European countries have been identified, these will remain involved throughout the project. Communication activities so far include a twitter account, a project leaflet and newsletters.

WP8 concerns all ethical issues in the project, all deliverables have been submitted.

RISCC expects to establish risk-based screening strategies, which are effective, affordable and acceptable. These strategies will improve health outcomes and equity across Europe and show the potential of risk-based screening for cervical cancer and other diseases. Several steps have been made to develop risk profiles based on screening history, vaccination coverage and individual risk factors. Currently a pilot using (m-)health/e-health solutions to facilitate risk-based screening is ongoing in Sweden. Besides several dissemination and communication activities for researchers and other stakeholders, important efforts have been made to engage women and ensure proper communication to laypeople, therefore several local ambassadors have been identified. Given the ongoing pandemic, findings of RISCC will be of even larger interest. Many countries have offered self-sampling during the pandemic or have paused their screening programs temporarily, which makes prioritization of those at the highest risk even more important.

Figure 1

Periodic Reporting for period 1 - RISCC (RISK-BASED SCREENING FOR CERVICAL CANCER)

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