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
Current interventions as of 08/09/2017:
Before their colposcopy examination women, who have signed a consent form to take part, will firstly be asked to provide a sample of urine using a Colli-Pee collection kit. They will then 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.
They may continue to take the cervico-vaginal samples even if they cannot provide a urine sample.
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.
Previous interventions:
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 measure
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
01/12/2027
Reason abandoned (if study stopped)
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
16/08/2017
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
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 organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The aim would be to publish in a peer reviewed journal by 31/12/2019. There would also be the intention to present the data at either the 33rd International Papillomavirus Conference March 2020 or EUROGIN - European Research Organisation on Genital Infection and Neoplasia conference in December 2019.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list