Comparing self-taken samples from the vagina and urine with samples taken by a doctor or nurse in women between 25-65 years who test positive for HPV

Comparison of high-risk positivity of a vaginal self-sample and urine sample with a clinician-taken cervical sample taken at the same screening visit

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78093478

Enrollment

216

Registered

2025-02-25

Start date

2024-05-01

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

HPV screening for cervical cancer Cancer

Interventions

The primary objective of Phase 1 is to evaluate the analytical suitability of storage and laboratory processes to test self-samples using wet and dry self-collection methods for vaginal and urine samp

one swab will be used as a 'wet' swab where the swab will placed into a medium and one 'dry' swab which does not involve the use of a medium. Participants will be asked to provide a second 3 ml urine

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women aged between 25-65 years attending the colposcopy clinic as a consequence of abnormal screening cytology and or positive HPV result

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant 2. Women do not have a cervix 3. History of ablative or excisional treatment for CIN within the last 3 years

Design outcomes

Primary

Measure	Time frame
Quality of DNA (binary) measured using the LabChip GX (PerkinElmer) at each timepoint the sample has been assigned. A GQS of >1.5 will be deemed acceptable sample quality.	—

Secondary

Measure	Time frame
1. Quantity of DNA (ng/ml) as measured using the Qubit Fluorometer (ThermoFisher Scientific) at each timepoint the sample has been assigned 2. Minimum HPV Ct value across all channels measured by the BD assay at each timepoint the sample has been assigned 3. HPV Ct value for each channel, if there’s no infection HPV Ct value will be assigned 40, because they were referred based on having an HPV-positive clinician sample. Measured at each timepoint the sample has been assigned. 4. The time to resuspension in days (continuous) will be calculated as resuspension date – sample collection date 5. S5 overall score (range 0-100, unitless) measured using Pyrosequencing - Pyromark Q48 at timepoints immediately, after 1 week and after 2 weeks from collection 6. The number of 3 ml urine samples returned to the lab measured using the BD Viper™ LT system (BD Viper™ LT system offers fully automated molecular testing for the BD Onclarity™ HPV assay) immediately (there are no timepoints for the 3 ml urine samples)	—

Measure

Time frame

1. Quantity of DNA (ng/ml) as measured using the Qubit Fluorometer (ThermoFisher Scientific) at each timepoint the sample has been assigned 2. Minimum HPV Ct value across all channels measured by the BD assay at each timepoint the sample has been assigned 3. HPV Ct value for each channel, if there’s no infection HPV Ct value will be assigned 40, because they were referred based on having an HPV-positive clinician sample. Measured at each timepoint the sample has been assigned. 4. The time to resuspension in days (continuous) will be calculated as resuspension date – sample collection date 5. S5 overall score (range 0-100, unitless) measured using Pyrosequencing - Pyromark Q48 at timepoints immediately, after 1 week and after 2 weeks from collection 6. The number of 3 ml urine samples returned to the lab measured using the BD Viper™ LT system (BD Viper™ LT system offers fully automated molecular testing for the BD Onclarity™ HPV assay) immediately (there are no timepoints for the 3 ml urine samples)

—

Countries

England, United Kingdom

Contacts

Public ContactRanjit Manchanda

r.manchanda@qmul.ac.uk+44 (0)207 882 5555

Outcome results

None listed

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