The GRECOSELF study

PRIMARY HPV-BASED SELF-SAMPLING SCREENING WITH THE COBAS® HPV TEST FOR UNDERSERVED GREEK WOMEN

Funding Body: Roche Diagnostics Hellas – Bodossakis Foundation

In recent years, advances in the design, validation and routine implementation of diagnostic molecular biology techniques in cervical cancer screening have been complemented by the development of protocols aimed at improving the sampling collection itself, particularly self-sampling, making it more accessible, easy and cost effective than the clinician-based collection method, especially for countries with low coverage of the screening population ( in Greece this percentage is no more than 30%!). This alternative method should have as a target group those women not participating in national screening programmes and, especially, women living in low-income settings with poor access to health services. Several devices used for the self-collection of cervicovaginal samples have been developed to this purpose and assessed in large scale screening studies. Relevant to mention, a meta-analysis has shown that the identification of hrHPV on self-collected samples using PCR-based methods does not yield a statistically significant difference in diagnostic accuracy compared to that performed on clinician-collected samples.

The rationale of the GRECOSELF Study is grounded on the use of the simple Roche® self-collection cervicovaginal specimen device by underscreened women residing in rural areas of Greece, and the identification of hrHPV DNA on the cervicovaginal self-collected samples using a FDA-approved method for primary cervical cancer screening (cobas®4800, Roche®). The aims of the study are (i) to assess the performance of self-sampling HPV-based screening in underserved Greek women, in comparison to historical real-life cytology-based screening results in populations with limited access to health-care units; and, (ii) to assess the acceptability of the novel collection method.

Women (sample target size n=12,700) 25-60 years old, residing in rural areas in Greece, are contacted by midwifes, via public announcement, and after providing written informed consent, are given a self-sampling kit (Roche®). After sampling each woman fills in a questionnaire designed to assess cervical cancer screening participation and outcome history during the last 10 years, and the acceptance of the self-sampling procedure. Samples are tested using the cobas®4800 HPV Test, Roche®, which detects HPVs 16 and 18 separately, and HPVs 31,33,35,39,45,51,52,56,58,59,66 and 68 as a pooled result. HPV-positive women are referred for colposcopy. In case of Cervical Intraepithelial Neoplasia (CIN) grade 1 or 2 or worse (CIN2+) they are referred to follow up or appropriate treatment respectively.

Between May 2016 and Sept. 2017, 9,876 samples were collected, 9,750 of which were tested; of these 755 (7.74%) were HPV-positive. Overall, 358 colposcopies were performed and CIN 1, 2 and 3 was detected in 34, 17, and 16 cases, respectively. Additionally, there were two cases of vaginal intraepithelial neoplasia and a case of cervical adenocarcinoma. The prevalence of high-grade disease or cancer among HPV-positive women examined was 9.2%.

The preliminary results of the GRECOSELF study concerning the prevalence of high grade precancerous or cancerous lesions of the uterine cervix among the examined female population appear equal to the expected ones for Greece, especially for women residing in rural areas, showing that HPV-testing on self-collected cervicovaginal samples is a feasible and effective cervical cancer prevention method for Greek women residing in remote areas with limited access to health services.


Main Investigators:
Theodoros Agorastos, Professor of Obstetrics and Gynecology, Director of the IV University Clinic of Obstetrics and Gynecology AUTh
Kostas Stamatopoulos, Director of the Institute of Applied Biosciences – Centre for Research and Technology Hellas


Contact

Email:inab@certh.gr