Comparing different ways to take self-samples for HPV testing for cervical screening

ISRCTN ISRCTN68980717
DOI https://doi.org/10.1186/ISRCTN68980717
Secondary identifying numbers 20833
Submission date
18/04/2016
Registration date
22/04/2016
Last edited
25/08/2021
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-a-urine-sample-and-different-ways-of-collecting-and-transporting-vaginal-samples

Contact information

Ms Louise Cadman
Public

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

ORCiD logoORCID ID 0000-0002-0821-3567

Study information

Study designRandomised; Interventional; Design type: Screening, Imaging
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSpecialty: Cancer, Primary sub-specialty: Gynae; UKCRC code/ Disease:
InterventionCurrent 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 typeOther
Primary outcome measure1. 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 measuresHistological and cytological outcomes and total scores allocated by women to each test on the acceptability questionnaire
Overall study start date15/03/2016
Completion date01/12/2027

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned Sample Size: 600; UK Sample Size: 600
Key inclusion criteria1. 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
Key exclusion criteria1. Pregnancy
2. History of excisional or ablative treatment for CIN within the last three years
Date of first enrolment22/04/2016
Date of final enrolment16/08/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study 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

Bart’s Health NHS Trust
Hospital/treatment centre

Dr Mays Jawad
Research & Development Governance Operations Manager
Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom

ROR logo "ROR" https://ror.org/00b31g692

Funders

Funder type

Government

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe 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.
IPD sharing plan

Editorial Notes

25/08/2021: Cancer Research UK lay results summary link added to Results (plain English).
18/01/2019: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 12/04/2018 to 01/12/2027
2. The intention to publish date has been changed from 31/07/2018 to 31/12/2019
3. The publication and dissemination plan has been changed to reflect the changes above
4. The sponsor address has been updated
08/09/2017: Recruitment end date has been updated from 21/04/2017 to 16/08/2017. Interventions have been updated.
17/03/2017: Cancer Help UK lay summary link added to plain English summary field.
06/02/2017: Internal review.