rine HPV testing in women over 65 years of age
Not Applicable
- Conditions
- Identification of cervical cancer risk in women over 65 years of age using urine HPV testingCancerMalignant neoplasm of cervix uteri
- Registration Number
- ISRCTN39388293
- Lead Sponsor
- niversity of Manchester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 3000
Inclusion Criteria
1. Age 65-79 years
2. Written, informed consent to participate
3. Attending MFT Community based lung health check
4. Female or person with a cervix
Exclusion Criteria
1. Previous total hysterectomy (no cervix)
2. Unable to provide a urine sample
3. Unable to understand the Patient Information Sheet and consent form
4. 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 Prevalence of HR-HPV in females over 65 years of age measured using a urine sample tested for HR-HPV at baseline
- Secondary Outcome Measures
Name Time Method <br> 1. Acceptability of urine HPV testing to high-risk past-attenders and non-attenders of routine cervical screening assessed via participant questionnaire at baseline<br> 2. Feasibility of a ‘one-stop-shop’ that combines cervical and lung screening assessed by uptake of participant appointments over the course of the trial<br> 3. Prevalence of HR-HPV according to screening history in women aged 65-79 years assessed by participant questionnaire at baseline<br> 4. Cervical screening outcomes in women who test HR-HPV positive, including compliance with routine cervical screening, colposcopy, and biopsy, assessed at the final point of treatment or within 12 months<br>