Self- Sampling in Cervical Cancer Routine Screening | NCT06931184

Studies
Self- Sampling in Cervical Cancer Routine Screening

NCT06931184

Sponsor

Tampere University Hospital

Status

Enrolling by invitation

Last Update Posted

Apr 17, 2025Actual

Enrollment

40,000Estimated

Phase

Not Applicable

Conditions

Cervical Cancer Screening

Interventions

self-sampling

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Feb 21, 2025

First Submission Date that Met QC Criteria

Apr 9, 2025

First Posted Date

Apr 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2025

Last Update Posted Date

Apr 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karolina Louvanto, Professor of Obstetrics and Gynecology, Tampere UniversityPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-Sample	Other	Cervical cancer screening taken with self-sampling kit to increase the coverage of screening.	Other: self-sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
self-sampling	Other	increase screening coverage by self-sampling	Self-Sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

woman

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital and Tampere University		Tampere	Pirkanmaa	33520	Finland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD that underlie results in a publication

Types

Not provided

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.

URL

Not provided