Human Papilloma VirusVALMUDESNCT07768787
Validation of Vaginal Self-Sampling With the Abbott Multi-Collect Swab for HPV Screening in Women Aged 30 to 64 Years
An observational study of Human Papilloma Virus and Human Papilloma Virus Related Cervical Carcinoma, run by AML at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Human Papilloma Virus Related Cervical Carcinoma, Cervical Carcinoma
- What is being tested?
- Abbott Multi-Collect Specimen Collection Swab
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Sep 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women attending a participating gynecology practice were recruited for this study. The population included women from a routine cervical cancer screening setting and women who had not recently participated in cervical cancer screening.
Who may be able to join
- 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.
Who cannot join
- Women treated for cervical cancer (hysterectomized).
- Pregnant women.
- Menstruating women
- Non-consenting women.
- Women unable to understand and/or sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Multi-Collect Device for Self-Sampling
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.
Read the detailed description
Human papillomavirus (HPV) testing is an important component of cervical cancer screening. Self-sampling may increase screening participation, particularly among women who do not regularly attend screening programs. The Multi-Collect Specimen Collection Swab (Abbott) is a self-sampling device that offers practical advantages for large-scale screening, including simplified sample handling and compatibility with automated laboratory workflows.
This single-center, observational, cross-sectional study evaluates the clinical performance of HPV testing on vaginal self-collected samples obtained using the Abbott Multi-Collect device. HPV test results from self-collected vaginal samples are compared with matched clinician-collected cervical samples obtained during the same visit. Samples are analyzed using the Alinity m HR HPV assay, the m2000 RealTime High Risk HPV Assay, and the RIATOL qPCR HPV genotyping assay.
The study includes women aged 30 to 64 years who either regularly participate in cervical cancer screening or have not attended screening for at least 3 years. The inclusion of screening non-attenders allows evaluation of test performance in a population that may particularly benefit from self-sampling approaches and provides a setting that reflects real-world implementation of HPV self-sampling.
The study aims to assess the relative clinical accuracy of HPV testing on self-collected versus clinician-collected samples and to evaluate agreement between different HPV assays. The findings are intended to support the clinical validation of the Abbott Multi-Collect device for vaginal self-sampling as a tool to help expand access to cervical cancer screening.
- Conditions
- Human Papilloma Virus, Human Papilloma Virus Related Cervical Carcinoma, Cervical Carcinoma
- Being tested
- Abbott Multi-Collect Specimen Collection Swab
- Keywords
- Vaginal self-sampling, VALMUDES, Cervical Cancer Screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Multi-Collect Specimen Collection SwabDevice
Vaginal self-sampling device used for collection of self-collected vaginal specimens for high-risk human papillomavirus testing.
| Study group | Role | What they receive |
|---|---|---|
| Regular Screening Attenders | 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. Receives: Device: Abbott Multi-Collect Specimen Collection Swab | |
| Screening Non-Attenders | Women aged 30 to 64 years who did not participate in cervical cancer screening during the previous 3 years or longer. Receives: Device: Abbott Multi-Collect Specimen Collection Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Sensitivity and Specificity of High-Risk HPV Testing on Self-Collected Versus Clinician-Collected Samples
Relative sensitivity and specificity of high-risk human papillomavirus (hrHPV) testing on vaginal self-collected samples compared with matched clinician-collected cervical samples using the Alinity m HR HPV assay, m2000 RealTime High Risk HPV Assay, and RIATOL qPCR HPV genotyping assay.
Measured: From enrollment through completion of protocol-defined follow-up, up to 12 months
Secondary outcomes (3)
Agreement Between High-Risk Human Papillomavirus Assays
Concordance of high-risk human papillomavirus (hrHPV) test results between the Alinity m HR HPV assay, m2000 RealTime High Risk HPV Assay, and RIATOL qPCR HPV genotyping assay on vaginal self-collected samples.
Measured: At enrollment
Absolute Sensitivity and Specificity for Detection of CIN2+
Absolute sensitivity and specificity of high-risk human papillomavirus testing on self-collected vaginal samples and clinician-collected cervical samples for the detection of underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
Measured: From enrollment through completion of protocol-defined follow-up, up to 12 months
Beta-Globin Positivity Rate
Positivity rates of the beta-globin sample adequacy control in self-collected vaginal samples and clinician-collected cervical samples
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start19 Sep 2024
- Primary completion6 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AML
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768787
- Sponsor's protocol ID
- R021-28
- Other IDs
- CIV-24-05-047445
- Acronym
- VALMUDES
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Multi-Collect Device for Self-Sampling
- ClinicalTrials.gov ID
- NCT07768787
- Acronym / sponsor ID
- VALMUDES / R021-28
- Conditions
- Human Papilloma Virus, Human Papilloma Virus Related Cervical Carcinoma, Cervical Carcinoma
- Keywords
- Vaginal self-sampling, VALMUDES, Cervical Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AMLIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Human papillomavirus (HPV) testing is an important component of cervical cancer screening. Self-sampling may increase screening participation, particularly among women who do not regularly attend screening programs. The Multi-Collect Specimen Collection Swab (Abbott) is a self-sampling device that offers practical advantages for large-scale screening, including simplified sample handling and compatibility with automated laboratory workflows.
This single-center, observational, cross-sectional study evaluates the clinical performance of HPV testing on vaginal self-collected samples obtained using the Abbott Multi-Collect device. HPV test results from self-collected vaginal samples are compared with matched clinician-collected cervical samples obtained during the same visit. Samples are analyzed using the Alinity m HR HPV assay, the m2000 RealTime High Risk HPV Assay, and the RIATOL qPCR HPV genotyping assay.
The study includes women aged 30 to 64 years who either regularly participate in cervical cancer screening or have not attended screening for at least 3 years. The inclusion of screening non-attenders allows evaluation of test performance in a population that may particularly benefit from self-sampling approaches and provides a setting that reflects real-world implementation of HPV self-sampling.
The study aims to assess the relative clinical accuracy of HPV testing on self-collected versus clinician-collected samples and to evaluate agreement between different HPV assays. The findings are intended to support the clinical validation of the Abbott Multi-Collect device for vaginal self-sampling as a tool to help expand access to cervical cancer screening.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Screening Attenders | – | Device: Abbott Multi-Collect Specimen Collection SwabWomen 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. |
| Screening Non-Attenders | – | Device: Abbott Multi-Collect Specimen Collection SwabWomen aged 30 to 64 years who did not participate in cervical cancer screening during the previous 3 years or longer. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women attending a participating gynecology practice were recruited for this study. The population included women from a routine cervical cancer screening setting and women who had not recently participated in cervical cancer screening.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Women treated for cervical cancer (hysterectomized).
- Pregnant women.
- Menstruating women
- Non-consenting women.
- Women unable to understand and/or sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott Multi-Collect Specimen Collection SwabVaginal self-sampling device used for collection of self-collected vaginal specimens for high-risk human papillomavirus testing. | Device | Regular Screening Attenders, Screening Non-Attenders |
Primary outcome
Relative Sensitivity and Specificity of High-Risk HPV Testing on Self-Collected Versus Clinician-Collected Samples
Time frame: From enrollment through completion of protocol-defined follow-up, up to 12 months
Relative sensitivity and specificity of high-risk human papillomavirus (hrHPV) testing on vaginal self-collected samples compared with matched clinician-collected cervical samples using the Alinity m HR HPV assay, m2000 RealTime High Risk HPV Assay, and RIATOL qPCR HPV genotyping assay.
3 secondary outcomes
Agreement Between High-Risk Human Papillomavirus Assays
Time frame: At enrollment
Absolute Sensitivity and Specificity for Detection of CIN2+
Time frame: From enrollment through completion of protocol-defined follow-up, up to 12 months
Beta-Globin Positivity Rate
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus and Human Papilloma Virus Related Cervical Carcinoma, run by AML at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Sensitivity and Specificity of High-Risk HPV Testing on Self-Collected Versus Clinician-Collected Samples (time frame: From enrollment through completion of protocol-defined follow-up, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.