Clinical trial · Observational
Long-Term Follow-Up of HPV FOCAL Participants
Evaluation of CIN2+ Rates up to 120 Months After 48-Month Co-Testing (Long Term Follow up of HPV FOCAL Participants)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV and cytology co-testing (via Liquid based collection device) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Control
- description
- 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.
- interventionNames
- Other: HPV and cytology co-testing (via Liquid based collection device)
Primary outcomes (1)
- measure
- Rates of CIN2+
- timeFrame
- 120 months
- description
- Moderately abnormal cells are found on the surface of the cervix
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 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
References
Publications (0)
Data not yet available