Long-Term Follow-Up of HPV FOCAL Participants

NCT04185389 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1710

Last updated 2026-04-28

No results posted yet for this study

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. 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.

Conditions

Interventions

OTHER

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

Liquid-based cytology co-testing is a procedure in which that a cervical sample is taken, and can be co-tested for HPV and standard cytology at the same time. It is collected in the same way that a traditional Pap is collected

Sponsors & Collaborators

  • British Columbia Cancer Agency

    collaborator OTHER
  • National Cancer Institute (NCI)

    collaborator NIH
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Gina Ogilvie, MD, MSc FCFP DrPH · University of British Columbia

  • Laurie Smith, MPH · BC Cancer

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-07-14
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185389 on ClinicalTrials.gov