Identification of cervical pre cancer in the general screening population using urine HPV testing Cancer
Conditions
Interventions
Current intervention as of 11/04/2023:
This study will see if a urine test can accurately identify individuals with cervical pre-cancer and those who continue to be HPV positive after treatment by com
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
24 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 24-70 years 2. Written, informed consent to participate 3. Undergoing routine NHS cervical screening or management of abnormal cervical screening
Exclusion criteria
Exclusion criteria: 1. Pregnant 2. Previous hysterectomy 3. Unable to provide a urine sample 4. Unable to understand the Participant Information Sheet and consent form 5. Any condition that would compromise participant safety or data integrity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. High risk HPV detection rate in matched urine and cervical samples at baseline 2. CIN2+ detection rates according to routine cervical screening outcomes The above measures will be used to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of the urine HPV test for CIN2+ detection compared to routine cervical screening | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Concordance of HR-HPV+ test results in matched urine and cervical samples measured as in the primary outcome measure at baseline 2. Presence of CIN2+ measured using urine HPV+ test combined with a methylation+ test at baseline (used to calculate diagnostic test accuracy (sensitivity, specificity, NPV and PPV) 3. Preference for urine compared to routine sampling for cervical screening assessed by participant questionnaire at baseline 4. Reasons for declining to take part in the study assessed by participant questionnaire at the time of declining | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Carter
Outcome results
None listed