Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

NCT ID: NCT07171658

Last Updated: 2025-12-22

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

RECRUITING

Clinical Phase

NA

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-07

Study Completion Date

2027-12-31

Brief Summary

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The primary objective of this clinical trial is to assess cervical cancer screening participation among under-screened women invited through organized breast cancer screening programs in Switzerland.

This randomized trial will compare three arms:

1. Intervention group 1: Sensitization to Cervical Cancer (CC) screening Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
2. Intervention group 2: Home-based Human papillomavirus infection (HPV) self-sampling Women will receive a free-of-charge vaginal self-sampling kit for HPV infection
3. Observational control group Women selected in the control arm will only be recruited one year following the screening of those in the intervention arm (T0+1), as to not influence Cervical Cancer Screening (CCS) behavior during this period by being reminded of screening recommendations.

Detailed Description

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Secondary objectives are:

* To identify and compare the association of socio-demographic characteristics with screening participation in all study arms (cf. 3.2 study design).
* To compare the use of primary screening methods (HPV test vs. Papanicolaou test) between study arms.
* To compare prevalence of positive primary screening and triage results between study arms.
* To compare follow-up rates for participants screened positive in both intervention arms.
* To evaluate acceptability of both screening strategies (sensitization vs. home-based).
* To assess the relationship between CCS behavior and Breast Cancer Screening (BCS) behavior.

Conditions

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Cervical Cancer Screening

Keywords

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cervical cancer screening underscreened women HPV self-sampling Integrated approach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a 1) population-based 2) randomized trial 3) two-arm 4) open 5) national hybrid 6) completed by an observational control arm .
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group 1: Sensitization to Cervical Cancer (CC) screening

Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.

Group Type EXPERIMENTAL

Sensitization to Cervical Cancer (CC) screening

Intervention Type BEHAVIORAL

Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.

Intervention Group 2: Home-based HPV self-sampling

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Group Type EXPERIMENTAL

Home-based HPV self-sampling

Intervention Type BEHAVIORAL

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Interventions

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Sensitization to Cervical Cancer (CC) screening

Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.

Intervention Type BEHAVIORAL

Home-based HPV self-sampling

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women receiving Breast Cancer Screening (BCS) invitation letters in the selected five cantons (Geneva, Bern (francophone), Jura, Neuchâtel, and Vaud)
* Aged 50 to 74 years old
* Not been screened for cervical cancer in the past three years
* Speaking one of the 6 languages of the study (French, German, Italian, and in English, Spanish, and Portuguese)

Exclusion Criteria

* Prior cervical cancer diagnosis,
* Hysterectomy
* Non consent to participate to the study
* Incapable of judgment or under tutelage
* Pregnancy
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role collaborator

Jessica Di Vincenzo Sormani

OTHER

Sponsor Role lead

Responsible Party

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Jessica Di Vincenzo Sormani

Professor assistant (tenure track)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jessica Di Vincenzo Sormani, PhD

Role: STUDY_DIRECTOR

Haute École de Santé de Genève (HEdS-GE)

Locations

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University Hospitals of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Jessica Di Vincenzo-Sormani, PhD

Role: CONTACT

Phone: +41 22 558 58 78

Email: [email protected]

Patrick Petignat, MD

Role: CONTACT

Facility Contacts

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Patrick Petignat, MD

Role: primary

Other Identifiers

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32HW-0_228666

Identifier Type: -

Identifier Source: org_study_id