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

Not Applicable

• Conditions: Specialty: Cancer, Primary sub-specialty: Gynae; UKCRC code/ Disease: Cancer; Human papilloma virus (HPV)

• Registration Number: ISRCTN68980717
• Lead Sponsor: Bart’s Health NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-22
• Last Update Posted: 7 September 2021
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 600

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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