Condition category
Infections and Infestations
Date applied
02/10/2015
Date assigned
06/10/2015
Last edited
06/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical screening is a method of preventing cancer by detecting and treating early abnormalities which, if left untreated, could lead to cervical cancer. Infection with some high-risk types of human papilloma virus (HPV) can increase the risk of developing cervical cancer. Evidence from several studies has shown that testing for HPV infection is more effective at preventing cervical cancer than cytology (taking a sample of cervical cells). The Xpert HPV test is a way to rapidly detect high-risk HPV infection. It is performed using a special liquid medium (PreservCyt). However, storage of the liquid is not practical. Our aim is to evaluate the possibility of women self-sampling using dry swabs for HPV detection with the Xpert HPV test.

Who can participate?
Women age over 18 attending the colposcopy clinic.

What does the study involve?
Each patient is asked to provide two samples for HPV testing. They are first asked to perform self-sampling using a dry swab and then the doctor or nurse collects a second sample using a liquid medium. All samples are tested for high-risk HPV using the same test (Xpert HPV test). Patients later obtain their HPV test results and are managed accordingly.

What are the possible benefits and risks of participating?
Participating in the study has no direct and immediate benefits. However, if we prove that dry swabs are as good as the standard method for HPV detection using the Xpert HPV, it will help with cervical screening in developing countries by reducing the need for repeated visits. It will also help to increase participation in screening programs in developed countries by giving women alternatives for screening that might be more adapted to their busy schedule or budget. This study will not have any risks for the participants’ health.

Where is the study run from?
University Hospitals of Geneva (Switzerland).

When is the study starting and how long is it expected to run for?
September 2014 to October 2015.

Who is funding the study?
Hôpitaux Universitaires de Genève (Switzerland).

Who is the main contact?
Dr Rosa Catarino

Trial website

Contact information

Type

Public

Primary contact

Dr Rosa Catarino

ORCID ID

http://orcid.org/0000-0002-5317-7710

Contact details

Boulevard de la Cluse 30
Geneva
1205
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Validation study of vaginal dry swabs using the Xpert HPV test for human papillomavirus diagnosis

Acronym

Study hypothesis

Dry swabs performance is equivalent to the performance of standard physician-collected samples with swab immediately immersed in PreservCyt for HPV detection using the Xpert HPV test.

Ethics approval

The Cantonal Human Research Ethics Commission of Geneva (CCER), 30/11/2014, CER: 14-228

Study design

Observational

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human papillomavirus infection

Intervention

Women will be invited to perform two samplings for HPV testing. Women will firstly be asked to perform a Self-HPV using a dry swab (S-DRY) and then the physician or nurse will perform a cervical collection immersed in PreservCyt (dr-WET). All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic test (Xpert HPV). Later, the remaining sample immersed in PreservCyt will be tested for HPV DNA using cobas HPV test.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Agreement between the S-DRY and dr-WET samples concerning HPV types and HPV positivity will be measured using the kappa statistic (ĸ).

Secondary outcome measures

1. Sensitivity and specificity will be calculated for each method, using the cobas HPV test results as reference. Cytological results will also be used as a reference.
2. We will also analyze invalid test results using the Xpert HPV test and the delay between self collection and HPV analysis

Overall trial start date

01/09/2014

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥ 18 years
2. Attending colposcopy clinic
3. Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant exclusion criteria

1. Pregnancy
2. Previous hysterectomy

Recruitment start date

04/03/2015

Recruitment end date

31/10/2015

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospitals of Geneva
Geneva
1205
Switzerland

Sponsor information

Organisation

University Hospitals of Geneva (Switzerland)

Sponsor details

Boulevard de la Cluse 30
Geneva
1205
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hôpitaux Universitaires de Genève

Alternative name(s)

Geneva University Hospitals, HUG

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Switzerland

Results and Publications

Publication and dissemination plan

All data obtained from this study will be available. The results will be published in a scientific journal.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes