Diagnostic accuracy of urine HPV testing for cervical screening Infections and Infestations
Conditions
Interventions
Current intervention as of 11/04/2023:
This study will see if a urine test can accurately identify women with cervical pre-cancer and those who continue to be HPV-positive after treatment by comparing
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
24 Years to 70 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HR HPV measured in urine sample at baseline 2. CIN2+ via routine cervical screening obtained from clinical test results The above measures will be used to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of the urine HPV test | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/04/2023: 1. Presence of clinically important HPV infection measured using urine HPV / methylation test at baseline (used to calculate diagnostic test accuracy (sensitivity, specificity, NPV and PPV)) 2. HPV results from urine collected via a plain sterile urine pot and urine collected via Colli-Pee or alternative sampling device at baseline 3. Preference for urine or vaginal sampling compared to routine sampling for cervical screening assessed by participant questionnaire at baseline 4. To measure the concordance of urinary, vaginal and cervical HPV test results _____ Previous secondary outcome measures: 1. Presence of clinically important HPV infection measured using urine HPV / methylation test at baseline (used to calculate diagnostic test accuracy (sensitivity, specificity, NPV and PPV)) 2. HPV results from urine collected via a plain sterile urine pot and urine collected via Colli-Pee or alternative sampling device at baseline 3. Preference for urine compared to routine sampling for cervical screening assessed by participant questionnaire at baseline | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Carter
Outcome results
None listed