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
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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COMPLETED
NA
308 participants
INTERVENTIONAL
2016-08-28
2021-02-23
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
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.
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.
Usual care (Pap test)
Intervention: invitation to participate to the screening process by means of the usual care (pap-test).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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…)
30 Years
65 Years
FEMALE
Yes
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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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
Countries
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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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