Self- Sampling in Cervical Cancer Routine Screening

Not Applicable

• Conditions: Cervical Cancer Screening

• Registration Number: NCT06931184
• Lead Sponsor: Tampere University Hospital

Brief Summary

SELF-SAMPLING IN CERVICAL CANCER ROUTINE SCREENING (FALCON) -Study implements a self-sampling option for the non-attendees of the national cervical cancer screening program in the Wellbeing Services County of Pirkanmaa. HPV primary testing is currently preferred method for cervical cancer screening. The HPV-DNA self-sampling has been shown to have screening performance equal to that of provider-obtained samples. In 2024, those turning 30, 35, 40, 45, 50, 55, 60, or 65 had the opportunity to participate in the FALCON study if they do not respond to the first invitation to cervical cancer screening. From March 2025 also women living in Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia can take part to the study.

The main objective of the FALCON study is to increase the current coverage of the cervical cancer screening program in the Pirkanmaa, Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia region and assess how acceptable self-sampling is for women.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-11
• Study First Submitted: 2025-02-21
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40000

Inclusion Criteria

• Women that do not respond to the first national cervical cancer screening invitation in 2024 and 2025 and to whom the reminder letter is sent to.
• Birth cohorts of women who will turn in screening year: 30, 35, 40, 45, 50, 55, 60 or 65 years old.

Exclusion Criteria

• Women who do not belong to the screening year 2024 or 2025 invitation birth cohorts.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in screening participation in a screening year	From baseline to the end of screening year, an average of 1 year	Increase the cervical cancer screening coverage in the Wellbeing Services County of Pirkanmaa and women living in Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia via offering self-sampling option to those non-attendees and evaluate the self-sampling preference options among women.

Trial Locations

Locations (1)

Tampere University Hospital and Tampere University; 🇫🇮 Tampere, Pirkanmaa, Finland