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Enrolling by invitationNCT06931184FALCONUpdated Apr 17, 2025

Self- Sampling in Cervical Cancer Routine Screening

An interventional study of self-sampling in Cervical Cancer Screening, sponsored by Tampere University Hospital. Enrolling by invitation at 1 site in Finland. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Tampere University Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 8 months after the study started (first participant enrolled Jun 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40,000
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cervical Cancer Screening
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 40,000 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Women who do not belong to the screening year 2024 or 2025 invitation birth cohorts.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40,000 participants (estimated)

Study arms

  • Other
    Self-Sample

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

    Other: self-sampling

Interventions

  • Otherself-sampling

    increase screening coverage by self-sampling

06

What researchers measure

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.

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

07

Study locations

1 site
  • Tampere University Hospital and Tampere University
    Tampere, Pirkanmaa 33520, Finland
08

References and documents

Individual participant data

Plan to share: Yes — IPD that underlie results in a publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06931184
Lead sponsor
Tampere University Hospital
Responsible party
Karolina Louvanto (Professor of Obstetrics and Gynecology, Tampere University) — Principal investigator
First posted
Apr 17, 2025
Start date
Jun 11, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Apr 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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