Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner

NCT ID: NCT02749110

Last Updated: 2021-10-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-28

Study Completion Date

2021-02-23

Brief Summary

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This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.

Detailed Description

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In France screening for cervical cancer (CC) is usually based on an opportunistic screening program. French guidance recommends performing a smear every 3 years from the age of 25 to 65 years, after 2 initial normal yearly smears. Pap-tests can be carried out by medical doctors or midwifes. The coverage rate is estimated between 56.6% and 83.0%. In deprived populations, about 55% of women are unscreened as their risk to develop a CC is majored. The gynecologic examination and the consultation of a gynecologist appear to be the main barriers to the pap-test. Almost all these unscreened women visit their family physician at least yearly for themselves or with a relative, but many family physicians do not perform pap-tests. Our hypothesis is that more women are to be screened if they are invited to by their family physician (who carries out the pap-test himself or who refers the woman to a gynecologist or a midwife), and that the screening rate will be majored if the family physician delivers to his female patients, who are not willing to undergo a pap-smear, a vaginal self-sampling device.

To demonstrate this, we will conduct an open label 1:1 cluster randomized controlled trial. As the gender of the physician and his ability to carry out pap-tests is associated to the rate of his listed screened female patients, randomization will be stratified on these two variables. The 24 participating physicians (12 in each study arm) will enroll 2000 unscreened female patients. The study population will be all the social security insured unscreened listed women aged from 30 to 65 years of the participating physicians. As the specificity of the HPV-test to screen for CC is insufficient before the age of 30, woman between 25 and 29 years of age will not be part of the study.

All these women (unless an exclusion criterion appears in their medical record) will receive from their family physician an invitation letter to make an appointment for an encounter dedicated to CC screening. Women who accept to be enrolled in the study will sign a consent form and will be invited to fill in a questionnaire about their socio-economic profile and their beliefs and attitudes about prevention, cancer screening in general and screening for CC in particular. Participation to the screening process is not necessary for inclusion. Women in the control arm will be solely proposed to undergo a pap-test performed by their family physician or a gynecologist or a midwife. Women in the intervention arm will be alternatively proposed to proceed to an at home performed vaginal self-collection of a sample that is to be send by post to a centralized lab for HPV testing. HPV tests will be conducted by the virology lab of the University Hospital of Lille.

All screened negative women in both arms of the study will be considered as successful outcomes and finish the study. HPV screened positive women from the self-collection arm will be proposed a triage pap-test or colposcopy. Further 18 months follow-up will be matching French guidelines.

Conditions

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Malignant Tumor of Cervix Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Self-sampling for HPV test

Invitation to participate to the screening process by means of the usual care (pap-test) or the provision of a vaginal self-sampling brush (Evalyn Brush°). Self-collected samples are mailed to a central lab for HPV testing.

Group Type EXPERIMENTAL

Vaginal self-sampling brush

Intervention Type DEVICE

Self-collection by unscreened women aged from 30 to 65 of a vaginal sample with the device. After collection, the whole device is mailed in a normalized for biological samples package to the virology lab of the University Hospital of Lille where a HPV test is conducted using a Cobas 4800 technique.

Usual care (Pap test)

Intervention: invitation to participate to the screening process by means of the usual care (pap-test).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vaginal self-sampling brush

Self-collection by unscreened women aged from 30 to 65 of a vaginal sample with the device. After collection, the whole device is mailed in a normalized for biological samples package to the virology lab of the University Hospital of Lille where a HPV test is conducted using a Cobas 4800 technique.

Intervention Type DEVICE

Other Intervention Names

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Evalyn Brush European Community (EC) certificate N°: 44232121392

Eligibility Criteria

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Inclusion Criteria

* To be a woman
* Aged from 30 to 65 years (30 and 65 years included)
* Without reimbursement of a pap-test by the health insurance for more than 3 years, despite a reminder mailed by the health insurance on the previous year (list set up by the health insurance).
* Able to understand and sign voluntarily the consent to participate
* Warranted by the health insurance
* Able to understand and answer the questions of the study questionnaire alone or with the help of a self-chosen third party.

Exclusion Criteria

* No vaginal intercourse ever
* Pap-test quoted on another budget (hospital, mother and child protection…) conducted less than 3 years ago
* Known cervical lesion or known HPV status
* History of hysterectomy
* History of conisation
* History of laser treatment of the cervix
* History of cervical cancer
* Other medical reason to delay cervical cancer screening
* Abroad for more than one year
* Moving to another region (done or expected)
* Pregnant or breastfeeding
* Screening not relevant from the practitioner's perspective (Emergency situation, comorbidity…)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Berkhout, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Doctor's office 115

Herzeele, , France

Site Status

Countries

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France

References

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Other Identifiers

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2015-A01331-48

Identifier Type: OTHER

Identifier Source: secondary_id

LIC-14-14-0615

Identifier Type: OTHER

Identifier Source: secondary_id

2015_08

Identifier Type: -

Identifier Source: org_study_id

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