Self- Sampling in Cervical Cancer Routine Screening

NCT ID: NCT06931184

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-11

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Cervical Cancer Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Self-Sample

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

Group Type OTHER

self-sampling

Intervention Type OTHER

increase screening coverage by self-sampling

Interventions

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self-sampling

increase screening coverage by self-sampling

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karolina Louvanto

Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital and Tampere University

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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R23093

Identifier Type: -

Identifier Source: org_study_id

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