Condition category
Cancer
Date applied
24/04/2015
Date assigned
22/05/2015
Last edited
03/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Human papillomavirus (HPV) detection is useful for cervical cancer screening. We are carrying out a study of 130 women to compare the acceptability and analytic performance of two dry storage and transportation devices, FTA elute cartridge and Vaginal Dry Swabs for HPV testing. Our goal is to simplify the method of sampling and transport for HPV detection. The study's findings should help to improve women’s well-being by using the most cost-effective strategy for HPV screening. If self-collection using simple vaginal dry swabs proves to be as sensitive as the standard HPV testing (sample collected by a physician using a liquid medium) or the actual new alternatives, the FTA cartridge, it will contribute to the development and validation of this method for HPV screening.

Who can participate?
Women, aged at least 30 years from the colposcopy clinic of the Geneva University Hospitals, Switzerland.

What does the study involve?
Over a period of one year, participants are invited to perform two self-sampling (using the FTA card and the vaginal dry swab). Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the “first” test. All specimens are tested for the same pathogens (HR-HPV) using the same diagnostic test (Real-time PCR). At the end of the study, we compare the agreement between collection methods in terms of HPV positivity.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to women worldwide, particularly in low resource countries, because the results of the study may influence how HPV screening will be carried out in the future. There are no risks inherent to this study.

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

When is study starting and how long is it expected to run for?
December 2013 to March 2015

Who is funding the study?
Funding has been provided by the University Hospitals of Geneva (Projets Recherche & Développement (PRD)).

Who is the main contact?
Rosa Catarino, RosaIsabel.PintoCatarino@hcuge.ch
Aline Bilancioni, Aline.Bilancioni@hcuge.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosa Catarino

ORCID ID

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

Contact details

Boulevard de la Cluse 30
Genève
1205
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized comparison of two self-sampling methods (Vaginal dry swabs vs. FTA-elute cartridge) for HPV detection.

Acronym

Study hypothesis

Dry storage devices (FTA elute cartridge and Vaginal Dry Swabs) for self-sampling are well accepted among women and are equivalent to physician's collected sample using specimen transport medium.

Ethics approval

Cantonal Human Research Ethics Commission of Geneva, 17/.02/2014, ref: CCER, CER: 14-011

Study design

Women will be invited to perform two self-sampling (FTA and v-DRY) in our colposcopy clinic in Geneva. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic test (Real-time PCR).

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Cervical pre-cancer and cancer.

Intervention

Women were invited to perform two self-sampling (FTA and v-DRY). Randomization of the sequence of the two self-HPV tests was done to avoid potential bias that may advantage the “first” test.
The research nurse would then give oral instructions to the patients. For specimen collection, participants were instructed to wash their hands before the procedure. Each participant received a package containing specimen collection kit. The brush used for self-collection using the FTA cartridge was the Rovers Viva-brush (Rovers Medical Devices B.V., Oss, The Netherlands), whereas the swab used for the self-collection in the v-DRY method was the flocked mid-turbinate swab (Copan FLOQSwabs™; Copan, Italy). Recommendations were to hold the brush/swab by the end of the handle, to insert the brush/swab into the vagina, avoiding contact with the external genitalia, until they meet resistance (at least 6 cm). Once they met resistance, they should gently turn the brush/swab three to five times. Subsequently the brush should be applied to the FTA cartridge by pressing it onto the middle of sample area indicated and then rotate de brush 3-5 times across that area. On the other hand, the swab was just inserted inside its plastic sleeve (v-DRY).

During the colposcopy consultation, the physician collected also a sample using specimen transport medium (Copan ESwab, Brescia, Italy) for HPV testing.

HPV analysis was performed using the Anyplex II HPV28 (H28) Detection test (Seegene, Seoul, South Korea).

Intervention type

Device

Phase

Drug names

Primary outcome measures

Agreement between collection methods in terms of HPV positivity, measured using kappa statistic and corresponding standard deviation.

Secondary outcome measures

1. Sensitivity and specificity to detect high-risk HPV using the result from the physician’s collected samples as gold standard was reported, as well as, sensitivity and specificity of the three sampling methods for abnormal Pap smear. Because of the small number of high-grade squamous intraepithelial lesion (HSIL) or carcinomas in our population, we assessed sensitivity and specificity for low-grade squamous intraepithelial lesion or greater lesions (LSIL+). The two-tailed McNemar’s test was used for mutual comparison of sensitivity and specificity.
2. Positive and negative predictive values to detect high-risk HPV using the physician’s collected samples as gold standard
3. Positive and negative predictive values of the three sampling methods to detect high-risk HPV for abnormal Pap smear results
4. Agreement between collection methods in terms of HPV positivity, according to cytological results
Agreement between collection methods according to cytological results was measured using kappa statistic and corresponding standard deviation
5. Proportion of positive agreement (PPA) between paired FTA and Vaginal dry swabs (v-DRY) samples. The proportion of positive agreement (PPA) between paired FTA and v-DRY samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both dry samples, f1=the number of samples that were positive for FTA and g1=the number of samples that were positive for v-DRY
6. Proportion of positive agreement (PPA) between paired self collection methods (combined results of FTA and v-DRY) and physician’s collected sample. The proportion of positive agreement (PPA) between paired self collection methods and physician’s collected samples was calculated by using the following formula: 2a/(f1+g1), where a=the number of samples that were positive for HPV in both samples, f1=the number of samples that were positive for the self-collection methods and g1=the number of samples that were positive for the physician’s collected sample
7. Women’s preference regarding the collection methods. Women completed a self-administered questionnaire

Data will be analyzed with a statistical analysis software package (StataCorp.2013., Stata Statistical Software: Release 13. College Station, TX, USA).

Overall trial start date

01/12/2013

Overall trial end date

01/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least 30 years old
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

130

Participant exclusion criteria

1. Pregnancy
2. Previous Hysterectomy
3. Virgin
4. Not able to comply with protocol study

Recruitment start date

01/03/2014

Recruitment end date

28/02/2016

Locations

Countries of recruitment

Switzerland

Trial participating centre

Geneva University Hospitals
Boulevard de la Cluse 30
Genève
1205
Switzerland

Sponsor information

Organisation

Geneva University Hospitals

Sponsor details

Boulevard de la Cluse 30
Geneva
1205
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Research Projects for Development (Projets Recherche & Développement) (PRD) - HUG

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish all the results from this study in an international scientific journal by the end of the year 2015.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26630353

Publication citations

Additional files

Editorial Notes