Long-Term Follow-Up of HPV FOCAL Participants

NCT04185389 | Completed

• 2 other identifiers: H19-015845R01CA221918-02
• Study Type: observational
• Target: 1,710
• Locations: 1 country
• Sites: 1

Brief 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

Cervical Cancer

Keywords

hpv testing; cytology; human papillomavirus; cervix screening

Outcome Measures

Primary Outcomes (1)

• Rates of CIN2+

  Moderately abnormal cells are found on the surface of the cervix

  120 months

Study Arms (1)

Control

Women in the original HPV FOCAL control arm 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 submit another LBC sample for HPV and cytology co-testing.

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

Interventions

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

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

Control

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population consists entirely of participants from a previous RCT.

You may qualify if:

• Previous HPV FOCAL study, control arm participants who completed 48 month FOCAL LBC/HPV co-testing with no CIN2+ detected at trial exit
• Resident of BC
• \<69 years of age (upper age limit for routine screening per BC Cancer Cervix Screening program)
• No history of CIN2+ since FOCAL study exit or in the last 5 years
• Has not had a hysterectomy
• Has never had a diagnosis of invasive cervical cancer

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Cancer Agency: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Women's Health Research Institute

Vancouver, British Columbia, V6H3N1, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Gina Ogilvie, MD, MSc FCFP DrPH

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Laurie Smith, MPH

  BC Cancer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: September 30, 2020
• Primary Completion: July 14, 2022
• Study Completion: December 31, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)