Self- Sampling in Cervical Cancer Routine Screening

NCT06931184 | Enrolling By Invitation

• 1 other identifier: R23093
• Study Type: interventional
• Target: 40,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Change in screening participation in a screening 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.

  From baseline to the end of screening year, an average of 1 year

Study Arms (1)

Self-Sample

OTHER

Cervical cancer screening taken with self-sampling kit to increase the coverage of screening.

Other: self-sampling

Interventions

self-sampling OTHER

increase screening coverage by self-sampling

Self-Sample

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital and Tampere University

Tampere, Pirkanmaa, 33520, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: April 17, 2025
• Study Start: June 11, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication with no end date
• Access Criteria: IPD that underlie the results reported in a publication, after de-identification, will be available for researchers who provide a methodologically sound proposal with achievable aims. Proposals should be directed via e-mail to the PI of the study (KL); data requestors will need to sign a data access agreement.

Locations

FI (1)