rine human papillomavirus (HPV) testing for cervical pre-cancer screening

Not Applicable

• Conditions: Diagnostic accuracy of urine HPV testing for cervical screening; Infections and Infestations

• Registration Number: ISRCTN13132810
• Lead Sponsor: niversity of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-18
• Last Update Posted: 16 October 2023
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1420

Inclusion Criteria

Current inclusion criteria as of 18/01/2022:
1. Age 24 -70 years
2. Written, informed consent to participate
3. Attended or attending gynaecology or colposcopy clinic at Manchester University NHS Foundation Trust
4. Undergoing cervical screening, management of abnormal cervical screening or assessment of gynaecological symptoms

Previous inclusion criteria as of 28/09/2021:
1. Age 24 -70 years
2. Written, informed consent to participate
3. Attending gynaecology or colposcopy clinic at Manchester University NHS Foundation Trust
4. Undergoing cervical screening, management of abnormal cervical screening or assessment of gynaecological symptoms

Previous inclusion criteria:
1. Age 25 - 70 years
2. Written, informed consent to participate
3. Attending gynaecology or colposcopy clinic at Manchester University NHS Foundation Trust
4. Undergoing cervical screening, management of abnormal cervical screening or assessment of gynaecological symptoms

Exclusion Criteria

Current exclusion criteria as of 11/04/2023:
1. Pregnant
2. Previous hysterectomy
3. Unable to produce a urine sample and/or vaginal sample
4. Unable to comprehend the Patient Information Sheet and consent form
5. Any condition that would compromise participant safety or data integrity
_____

Previous exclusion criteria:
1. Pregnant
2. Previous hysterectomy
3. Unable to produce a urine sample
4. Unable to comprehend the Patient Information Sheet and consent form
5. Any condition that would compromise participant safety or data integrity

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. HR HPV measured in urine sample at baseline <br>2. CIN2+ via routine cervical screening obtained from clinical test results<br>The above measures will be used to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of the urine HPV test