Condition category
Cancer
Date applied
18/04/2016
Date assigned
22/04/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Ms Louise Cadman

ORCID ID

http://orcid.org/0000-0002-0821-3567

Contact details

Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20833

Study information

Scientific title

A randomised-assignment comparison study of the performance of self-collected vaginal samples for Human Papillomavirus (HPV) testing when transported under wet or dry conditions, using different collecting devices

Acronym

Study hypothesis

The aim of this study is to compare wet Dacron and dry flocked swabs and two commercially-designed devices to take a 'self-sample' for HPV testing

Ethics approval

Not provided at time of registration

Study design

Randomised; Interventional; Design type: Screening, Imaging

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Cancer, Primary sub-specialty: Gynae; UKCRC code/ Disease:

Intervention

Before their colposcopy examination women, who have signed a consent form to take part, will be asked to take two self-samples, either:

1. Swabs (like cotton buds) - one taken with a Dacron swab and placed into a liquid specimen transport medium and one with a dry flocked swab and transported as a dry sample. The order in which samples are taken is randomised to avoid bias.

or

2. Qvintip and HerSwab self-test kits. This involves women taking a sample with a HerSwab collection device and a sample taken with a Qvintip device. Once again sample order will be randomised. 300 women will be put into each group and given an illustrated instruction sheet. They will also be asked to fill in a short questionnaire about how easy or difficult they found taking each sample. Any smear and biopsy results from the colposcopy, and over the following 9 months or so, will be collected from hospital records. Self-samples will be taken to the Centre for Cancer Prevention. HPV results will be not given to the woman or her doctor as we do not know how reliable they are for clinical care.

There is no active follow-up of participants. Passive follow-up of the collection of histology and cytology results will take place. Taking part in the study will not affect routine colposcopy care.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. The total amount of nucleic acid in the samples (including RNA)
2. Quantification of amplifiable human genomic DNA
3. Estimation of the viral load of HPV16 in the samples
4. Validated HPV platforms which will give quantifiable measures of HPV with some degree of typing

Secondary outcome measures

Histological and cytological outcomes and total scores allocated by women to each test on the acceptability questionnaire

Overall trial start date

15/03/2016

Overall trial end date

12/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women attending for colposcopic examination at the Royal London Hospital colposcopy clinic
2. Referred as a consequence of abnormal screening cytology and/or positive HPV result
3. Who have a cervix
4. Who give written informed consent
5. Aged 18 years and above

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 600; UK Sample Size: 600

Participant exclusion criteria

1. Pregnancy
2. History of excisional or ablative treatment for CIN within the last three years

Recruitment start date

22/04/2016

Recruitment end date

21/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal London Hospital
Bart’s Health Colposcopy Service Colposcopy Unit Gynaecology Outpatients Women’s Centre 8th Floor Whitechapel Road
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Bart’s Health NHS Trust

Sponsor details

c/o/ Dr Sally Burtles
Director of Research Development
Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The aim would be to publish in a peer reviewed journal by July 2018. There would also be the intention to present the data at either the 32nd International Papillomavirus Conference in September 2018 or EUROGIN - European Research Organisation on Genital Infection and Neoplasia conference in 2017 or 2018.

Intention to publish date

31/07/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review