Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by th… (NCT02749110) | Clinical Trial Compass
CompletedNot Applicable
Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner
France308 participantsStarted 2016-08-28
Plain-language summary
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.
Who can participate
Age range30 Years – 65 Years
SexFEMALE
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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…)
What they're measuring
1
Rate of women terminating the whole diagnostic process.
Timeframe: For screening: 12 months; for follow-up of screened positive subjets: 18 months