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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68980717
Enrollment
600
Registered
2016-04-22
Start date
2016-04-22
Completion date
Unknown
Last updated
2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Cancer, Primary sub-specialty: Gynae

Interventions

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

Sponsors

Bart’s Health NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

England, United Kingdom

Contacts

Public ContactLouise Cadman

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026