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Self-collected versus clinician-collected cervical samples for the detection of HPV infections

Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN77337300
Enrollment
505
Registered
2020-12-15
Start date
2018-08-01
Completion date
Unknown
Last updated
2022-08-22

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

Conditions

Cervical cancer, human papillomavirus (HPV) infection Cancer Cervical cancer, human papillomavirus (HPV) infection

Interventions

All women were screened by both self-sampling (using XytoTest) and clinician collected cytology (using ThinPrep). Both samples were HPV tested with HPV DNA (Abbott) and HPV mRNA (Proofer 7). All women

Sponsors

Hospital General de México
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Sexually active women 2. Aged between 30 and 65 years 3. Responded positively to the invitation

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding 2. Sexual activity =24 h before the collection of samples 3. History of medical or surgical treatment (radiotherapy, chemotherapy, hysterectomy, or cone biopsy) for cervical cancer

Design outcomes

Primary

MeasureTime frame
1. HPV test result for samples collected from the same patient using both the XytoTest and ThinPrep sampling devices measured using an HPV DNA test (Abbott RealTime HR HPV test) and an HPV mRNA test (PreTect HPV-Proofer 7) at a single timepoint

Secondary

MeasureTime frame
1. Patient-reported acceptability of the self-collected samples method measured using a four-question questionnaire directly after self-testing using the XytoTest device

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026