Catch-up screen project: A urine test for cervical screening

Catch-Up Screen Project: A urine test for cervical screening

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39222060

Enrollment

10000

Registered

2023-01-31

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening for cervical pre-cancer Cancer

Interventions

This is a one-arm study. The “Catch-up Screen” project will offer the identification of cervical pre-cancer using a catch-up HPV test from a urine self-sample taken at home by women aged 60-79 who hav

Eligibility

Sex/Gender

Female

Age

60 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Female or person with a cervix who is registered with GP practice 2. Ceased from the NHS Cervical Screening Programme without an exit primary HPV test 3. Aged 60-79 years at invitation

Exclusion criteria

Exclusion criteria: 1. Previous total hysterectomy 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 5. Those who have opted out of sharing data for research purposes (this includes Type 1 and Type 2/National opt-out)

Design outcomes

Primary

Measure	Time frame
1. Response rate measured as the number of urine samples received divided by the number of eligible women invited at the end of the recruitment period 2. Ease of performing urine test (acceptability) as measured on the feedback form at the time of consent 3. Preference of urine versus cervical test (acceptability) as measured on the feedback form at the time of consent 4. Colposcopy and histological diagnoses measured using patient records following colposcopy and histology as necessary 5. Cumulative cervical cancer incidence and mortality measured using the national registration at 10 years and 20 years	—

Measure

Time frame

1. Response rate measured as the number of urine samples received divided by the number of eligible women invited at the end of the recruitment period 2. Ease of performing urine test (acceptability) as measured on the feedback form at the time of consent 3. Preference of urine versus cervical test (acceptability) as measured on the feedback form at the time of consent 4. Colposcopy and histological diagnoses measured using patient records following colposcopy and histology as necessary 5. Cumulative cervical cancer incidence and mortality measured using the national registration at 10 years and 20 years

—

Secondary

Measure	Time frame
1. High Risk HPV prevalence measured using the proportion of urine samples testing HPV positive using the BD Onclarity assay at the end of the recruitment period 2. Measure the impact on response rates (as defined in primary outcome measure 1 above) of a follow-up phone call versus text message from the GP practice after the initial invitation	—

Countries

England, United Kingdom

Contacts

Public ContactChristine Rake

christine.rake@lshtm.ac.uk+44 (0)20 7636 8636

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026