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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02698423
Other study ID # CER 11-034
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date January 2016

Study information

Verified date May 2018
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.


Description:

Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.


Recruitment information / eligibility

Status Completed
Enrollment 667
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 69 Years
Eligibility Inclusion Criteria:

- No previous cervical cancer screening test in the last three years

Exclusion Criteria:

- pregnancy

- previous hysterectomy

Study Design


Intervention

Device:
Cobas HPV DNA Test
Women will receive a home-sent sample for HPV self-testing
Other:
Papanicolau test
Women will be invited to come in for a physician-performed Pap test

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing. 1 year
Secondary Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening. 1 year
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