Back to resultsFeasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care (DEPIST)
Primary Purpose
Cancer of the Uterine Cervix
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cobas HPV DNA Test
Papanicolau test
Sponsored by
About this trial
This is an interventional screening trial for Cancer of the Uterine Cervix
Eligibility Criteria
Inclusion Criteria:
- No previous cervical cancer screening test in the last three years
Exclusion Criteria:
- pregnancy
- previous hysterectomy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cobas HPV DNA test
Papanicolau test
Arm Description
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02698423
First Posted
February 23, 2016
Last Updated
May 10, 2018
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT02698423
Brief Title
Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
Acronym
DEPIST
Official Title
Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Uterine Cervix
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
667 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cobas HPV DNA test
Arm Type
Experimental
Arm Description
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Arm Title
Papanicolau test
Arm Type
Active Comparator
Arm Description
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Intervention Type
Device
Intervention Name(s)
Cobas HPV DNA Test
Intervention Description
Women will receive a home-sent sample for HPV self-testing
Intervention Type
Other
Intervention Name(s)
Papanicolau test
Intervention Description
Women will be invited to come in for a physician-performed Pap test
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
Description
Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No previous cervical cancer screening test in the last three years
Exclusion Criteria:
pregnancy
previous hysterectomy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be used for scientific publications.
Learn more about this trial
Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
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