Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care (DEPIST)

May 10, 2018 updated by: Prof. Patrick Petignat, University Hospital, Geneva

Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

667

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • previous hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cobas HPV DNA test
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Device: Cobas HPV DNA Test
Women will receive a home-sent sample for HPV self-testing
Active Comparator: Papanicolau test
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Other: Papanicolau test
Women will be invited to come in for a physician-performed Pap test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
Time Frame: 1 year
Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 11-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be used for scientific publications.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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