Clinical trial · Observational
Validation of Vaginal Self-Sampling With the Abbott Multi-Collect Swab for HPV Screening in Women Aged 30 to 64 Years
Validation of Multi-Collect Device for Self-Sampling
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the performance of HPV testing on vaginal self-collected samples obtained with the Abbott Multi-Collect device. The study compares HPV test results from self-collected vaginal samples with results from clinician-collected cervical samples in women aged 30 to 64 years who either participate regularly in cervical cancer screening or have not attended screening for at least 3 years. The goal is to determine whether self-sampling provides accurate detection of high-risk human papillomavirus (hrHPV) and could support broader participation in cervical cancer screening programs.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Human Papilloma Virus Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abbott Multi-Collect Specimen Collection Swab | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Regular Screening Attenders
- description
- Women aged 30 to 64 years who regularly participate in cervical cancer screening and had a negative high-risk human papillomavirus (hrHPV) result at their previous screening within the past 3 years.
- interventionNames
- Device: Abbott Multi-Collect Specimen Collection Swab
- label
- Screening Non-Attenders
- description
- Women aged 30 to 64 years who did not participate in cervical cancer screening during the previous 3 years or longer.
- interventionNames
- Device: Abbott Multi-Collect Specimen Collection Swab
Primary outcomes (1)
- measure
- Relative Sensitivity and Specificity of High-Risk HPV Testing on Self-Collected Versus Clinician-Collected Samples
- timeFrame
- From enrollment through completion of protocol-defined follow-up, up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 30-64 years. * Women that regularly attend screening with negative HR-HPV-result on the RIATOL assay at previous screen within the past 3 years OR women that did not attend screening during the past 3 years or longer. Exclusion Criteria: * Women treated for cervical cancer (hysterectomized). * Pregnant women. * Menstruating women * Non-consenting women. * Women unable to understand and/or sign informed consent.
References
Publications (0)
Data not yet available