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HPV Self-sampling in the General Population

NCT ID: NCT06749847

Last Updated: 2025-07-23

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

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2026-12-31

Brief Summary

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A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.

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Detailed Description

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In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a three-arm study
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Outreach

Women receive invitation letter with HPV self-sampling kit; Direct mailing of HPV self-sampling kit; Women receive HPV self-sampling kit with instructions; SMS reminder at 3 months if no participation; Assistance provided for triage cytology if HPV positive.

Group Type EXPERIMENTAL

Women receive invitation letter with HPV self-sampling kit

Intervention Type OTHER

Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.

Choice

Women receive an invitation letter offering a choice between ordering a free self-sampling kit or visiting a healthcare provider.

Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.

Group Type EXPERIMENTAL

Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

Intervention Type OTHER

Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.

Control arm

Standard invitation to visit healthcare provider for cervical cancer screening. Standard screening procedure. Follow standard organized screening program procedure. HPV self-sampling offered at 12-month reminder if no participation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Women receive invitation letter with HPV self-sampling kit

Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.

Intervention Type OTHER

Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women aged 30 to 65 years old
* Living in the study area (Departments of Marne and Aube, France)
* At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Exclusion Criteria

* Outside the target age (less than 30 years old, or 66 years old and more)
* Already participating in the current screening round
* Total hysterectomy
* History of cervical cancer
* Current follow-up for abnormal cervical screening result or cervical lesions
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Régional de Coordination des Dépistages des Cancers de Grand Est

UNKNOWN

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

CHU de Reims

OTHER

Sponsor Role collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aurélie BERTRAND-BRICE, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Cancer Screening Coordinating Centre, Marne site

Christine CLAVEL CRAVOISIER, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU REIMS

Hamza ACHIT, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Farida SELMOUNI, PhD

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer

Catherine SAUVAGET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer

Locations

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Regional Cancer Screening Coordinating Centre, Aube site

Troyes, Aube, France

Site Status RECRUITING

Regional Cancer Screening Coordinating Centre, Marne site

Reims, Marne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Farida Selmouni, PhD

Role: CONTACT

[email protected]
+33 4 72738485

Catherine Sauvaget, MD, PhD

Role: CONTACT

[email protected]
+33 4 72738485

Facility Contacts

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Lucie FIEVET, MD

Role: primary

[email protected]
03-26-84-93-31

Aurélie BERTRAND-BRICE, MD

Role: primary

[email protected]
03-25-41-62-87

Other Identifiers

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2023-215

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IEC/24-01

Identifier Type: -

Identifier Source: org_study_id

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