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
Contact information
Ms Louise Cadman
Public
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 ID |
0000-0002-0821-3567 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Screening, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/03/2016 |
| Completion date | 01/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 600; UK Sample Size: 600 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. History of excisional or ablative treatment for CIN within the last three years |
| Date of first enrolment | 22/04/2016 |
| Date of final enrolment | 16/08/2017 |
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
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
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" |
https://ror.org/00b31g692 |
|---|
Funders
Funder type
Government
Cancer Research UK
Private sector organisation / Other non-profit organizations
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 date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
| 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.
