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Long-Term Follow-Up of HPV FOCAL Participants

2019-12-10 01:21:16 | BioPortfolio

Summary

This FOCAL follow-up study aims to assess the long-term effectiveness and safety of primary HPV testing for cervical cancer screening. A cohort of participants from the original FOCAL study will be asked to see their health care provider to submit another cervical sample for cytology and HPV testing; when a visit to a health care provider is not possible, the option to self-collect a sample for HPV testing will be provided. This will permit evaluation of long term safety and effectiveness of primary HPV testing up to ten years after a participant's first screening in the FOCAL study and comparison of primary HPV testing to HPV and cytology co-testing.

Description

This study will evaluate the long-term effectiveness of primary HPV screening, with and without cytology co-testing at various time points and inform optimal algorithms for HPV-based cervical cancer screening. Specifically the project will compare rates of CIN2+ after primary HPV testing to rates of CIN2+ after baseline LBC testing followed by HPV and LBC "co-testing" at 48 months. We hypothesize that women who have a negative HPV result at baseline will have fewer CIN2+ lesions detected at 96 months or 120 months (or greater) after baseline than women who have a negative cytology (LBC) result at baseline, and who receive HPV/LBC co-testing at 48 months and at 96 months or greater after baseline.

Objectives

1. Determine detection rates of CIN2+ at approximately 48 months or 72 months (one sample only, depending on when women exited the trial) after the FOCAL 48 month exit HPV/LBC co-test screen in control arm women.

2. Compare CIN2+ rates from women in the intervention arm (HPV testing) at 48 month FOCAL HPV/LBC co-test screen, to CIN2+ rates of women in the control arm (LBC testing) receiving HPV/LBC co-testing up to 120 months or greater (if applicable). If CIN2+ outcomes are available beyond 120 months where available, this will be captured to ensure important endpoints are not missed because of a 120 month cut off. (For the remainder of this proposal, when indicating 120 months, this will include those with CIN2+ outcomes beyond 120 months).

3. Using passive follow-up by anonymized data linkage with the BC Cancer cervix screening registry, determine long term protection against CIN2+ up to 120 months after a negative HPV baseline result.

Women in the control arm (LBC testing at baseline) who completed the 48 month exit screen (HPV/LBC co-test) and who had no CIN2+ detected during the trial or at trial exit will be invited to participate. When women consented to participate in the HPV FOCAL trial, they were asked if they were interested in being contacted in the future for potential research studies related to cervical cancer. Women who indicated they would be interested and those who did not specifically state they did not want to be contacted, will be contacted.

An information letter will be sent to eligible participants with information describing the study. This information package will also include the consent form. Interested women will be asked to contact the study centre for more information or to decline if they do not want to participate.

When interested and potentially eligible women contact the study centre, study details will be provided to them, and initial eligibility will be determined. Electronic/email consent will be obtained for those wishing to participate. It is not possible to have face to face interactions with participants, given the nature of this trial, and electronic consent is the most feasible approach for this project. Electronic consent procedures will be followed per UBC guidelines and per US OHRP "Use of Electronic Consent" guidelines. https://www.fda.gov/media/116850/download.

After eligibility has been confirmed, women will be provided with one of two options for sample collection:

1. Women with a regular health care provider (HCP) will be directed to their usual HCP for a cervical sample collection with Liquid based cytology, permitting for both HPV and cytology testing on the same sample.

2. To ensure HPV testing is available to women who are unable to see a care provider for LBC collection (for HPV and cytology testing), women without a care provider will be offered the opportunity to self-collect a vaginal swab for cervical screening with HPV testing. A self-collection kit with instructions will be mailed to the participant, who will self-collect the specimen in the privacy of her home.

All LBC samples will be sent to the PHL for HPV and cytology testing.

In order to compare the results of post- 48month trial exit follow-up for women in the FOCAL control arm (who had baseline LBC testing) to women in the FOCAL intervention arm (who had baseline HPV testing), a data linkage will be conducted between the FOCAL study database, the Cervix Screening Program Registry and the BC Cancer Registry, using BC Cancer Registry Data Linkage established procedures.

Study Design

Conditions

Cervical Cancer

Intervention

HPV and cytology co-testing (via Liquid based collection device), HPV Self-Collection

Status

Not yet recruiting

Source

University of British Columbia

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-10T01:21:16-0500

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