Uterine Cervical NeoplasmsNCT06528184
Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
A study testing Self-sampled HPV DNA testing and Clinician-sampled HPV DNA test in people with Uterine Cervical Neoplasms, run by National Healthcare Group Polyclinics at 1 site in Singapore.
Trial summary
Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus (HPV) DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA… Read more about this study
- Who is it for?
- Ages 30 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Self-sampled HPV DNA testing and Clinician-sampled HPV DNA test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-69 years old female Singapore citizens
- Due for cervical cancer screening
- Engaged in sexual intercourse before
- Able to give informed consent
- Able to read and communicate in English, Chinese or Malay
Who cannot join
- Virgo intacta
- Pregnancy
- History of cervical cancer, precancerous cervical lesions and total hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Healthcare Group Polyclinics
Singapore, Singapore, 138543
Ng Xin Rong, MBBS, 65-90929973, xin_rong_ng@nhgp.com.sg
About this study
Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus (HPV) DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA testing alone.
The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 7.7%.
Read the detailed description
This study is a pragmatic, multi-center, 1:1 randomized controlled trial designed to evaluate the impact of self-sampling HPV DNA testing on clinical outcomes and cost-effectiveness in cervical cancer screening. The trial will compare 2 approaches to HPV DNA testing within public primary care settings.
Participants in the intervention arm will first be offered a clinician-sampling HPV DNA test. If they decline, they will be offered the option of self-sampling HPV DNA test. The control arm will follow the standard protocol of offering only the conventional clinician-sampling HPV DNA test, reflecting the current standard of care in cervical cancer screening.
This study seeks to provide robust evidence on whether self-sampling can improve clinical outcomes, be cost-effective and be feasibility implemented in routine public primary healthcare settings. The findings are expected to inform future guidelines and policies for cervical cancer screening programs.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Self-sampled HPV DNA testing, Clinician-sampled HPV DNA test
- 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.
Self-sampled HPV DNA testingDiagnostic test
Participants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab)
Clinician-sampled HPV DNA testDiagnostic test
Participants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab)
| Study group | Role | What they receive |
|---|---|---|
| Usual care arm | Active comparator | Participants will only be offered clinician-sampling for HPV DNA testing to determine if they are agreeable to undergo screening. Receives: Diagnostic Test: Clinician-sampled HPV DNA test |
| Intervention arm | Experimental | Participants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality. Receives: Diagnostic Test: Self-sampled HPV DNA testing; Diagnostic Test: Clinician-sampled HPV DNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of high-risk Human Papillomavirus (HPV) DNA
Difference in detection of high-risk HPV DNA between 2 arms
Measured: 3 months
Secondary outcomes (8)
Uptake of cervical cancer screening
Difference in uptake of cervical cancer screening between 2 arms. Based on the number of cervical cancer screening tests that are processed and have available results.
Measured: 3 months
Colposcopy referrals
Difference in colposcopy referrals between 2 arms. Based on the number of colposcopy referrals made to the tertiary hospital for abnormal cervical cancer screening test results in either arm.
Measured: 2 years
Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers
Difference in detection of CIN 2, CIN 3 and cervical cancers between both arms.
Measured: 2 years
Treatments for CIN 2, CIN 3 and cervical cancers
Difference in treated CIN 2, CIN 3 and cervical cancers between both arms. Based on the number of participants with CIN 2, CIN 3 and cervical cancers that have undergone treatments by a gynecologist in either arm.
Measured: 2 years
Cost-effectiveness of cervical cancer screening
Difference in cost-effectiveness of offering cervical cancer screening between both arms. This includes the cost of screening and follow-up visits in primary care, the cost of further investigations in primary and tertiary care and the cost of treatment for CIN and cervical cancer in tertiary care.
Measured: 2 years
Facilitators and barriers of uptake of cervical cancer screening
Assessing the factors associated with uptake of cervical cancer screening. These factors include demographics of participants (age, ethnicity, education level, marital status, housing type, employment status), Body Mass Index, obstetrics-related factors (menopausal status, pregnancies, previous cervical cancer screening tests, use of tampons or menstrual cups, previous HPV vaccinations) as well as beliefs and attitudes towards cervical cancer screening. These variables will be collected from questionnaires.
Measured: 1 year
Feasibility of self-sampling cervical cancer screening
Assessing the preferences for next screening and the experience of the sampling procedure (ease of conducting, comfort, anxiety, embarrassment, unpleasantness and trusting of results) from questionnaires.
Measured: 1 year
Risk factors for cervical cancer and CIN
Assessing the factors associated with cervical cancer and CIN. These factors include demographics of participants, family history of cervical cancer, smoking status, use of contraceptives, immunosuppressive conditions and sexual history and obstetrics-related factors. These variables will be collected from questionnaires.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start5 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group Polyclinics
- Sponsor type
- Other government
- Collaborators
- National Healthcare Group, Singapore, KK Women's and Children's Hospital
- Responsible party
- Principal investigator, Ng Xin Rong, National Healthcare Group Polyclinics
- Investigators
- Ng Xin Rong, MBBS, Principal investigator, National Healthcare Group Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528184
- Sponsor's protocol ID
- 2024/00194
- Other IDs
- SCS-GRA-2023-00253
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng XR, Quek IP, Pereira MJ, Molina JA, Ngeow J, Wong SKW. Randomised controlled trial evaluating the impact of different methods of HPV DNA testing for cervical cancer screening in Singapore's primary care settings: a study protocol. BMJ Open. 2025 Mar 24;15(3):e095091. doi: 10.1136/bmjopen-2024-095091.
PubMed 40132819
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
- ClinicalTrials.gov ID
- NCT06528184
- Acronym / sponsor ID
- 2024/00194
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- National Healthcare Group PolyclinicsOther government
- Collaborators
- National Healthcare Group, Singapore, KK Women's and Children's Hospital
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus (HPV) DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA testing alone.
The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 7.7%.
Detailed description
This study is a pragmatic, multi-center, 1:1 randomized controlled trial designed to evaluate the impact of self-sampling HPV DNA testing on clinical outcomes and cost-effectiveness in cervical cancer screening. The trial will compare 2 approaches to HPV DNA testing within public primary care settings.
Participants in the intervention arm will first be offered a clinician-sampling HPV DNA test. If they decline, they will be offered the option of self-sampling HPV DNA test. The control arm will follow the standard protocol of offering only the conventional clinician-sampling HPV DNA test, reflecting the current standard of care in cervical cancer screening.
This study seeks to provide robust evidence on whether self-sampling can improve clinical outcomes, be cost-effective and be feasibility implemented in routine public primary healthcare settings. The findings are expected to inform future guidelines and policies for cervical cancer screening programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care arm | Active comparator | Diagnostic Test: Clinician-sampled HPV DNA testParticipants will only be offered clinician-sampling for HPV DNA testing to determine if they are agreeable to undergo screening. |
| Intervention arm | Experimental | Diagnostic Test: Self-sampled HPV DNA testing, Diagnostic Test: Clinician-sampled HPV DNA testParticipants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30-69 years old female Singapore citizens
- Due for cervical cancer screening
- Engaged in sexual intercourse before
- Able to give informed consent
- Able to read and communicate in English, Chinese or Malay
Key exclusion criteria (3 listed)
- Virgo intacta
- Pregnancy
- History of cervical cancer, precancerous cervical lesions and total hysterectomy
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 |
|---|---|---|
| Self-sampled HPV DNA testingParticipants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab) | Diagnostic test | Intervention arm |
| Clinician-sampled HPV DNA testParticipants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab) | Diagnostic test | Intervention arm, Usual care arm |
Primary outcome
Detection of high-risk Human Papillomavirus (HPV) DNA
Time frame: 3 months
Difference in detection of high-risk HPV DNA between 2 arms
8 secondary outcomes
Uptake of cervical cancer screening
Time frame: 3 months
Colposcopy referrals
Time frame: 2 years
Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers
Time frame: 2 years
Treatments for CIN 2, CIN 3 and cervical cancers
Time frame: 2 years
Cost-effectiveness of cervical cancer screening
Time frame: 2 years
Facilitators and barriers of uptake of cervical cancer screening
Time frame: 1 year
Feasibility of self-sampling cervical cancer screening
Time frame: 1 year
Risk factors for cervical cancer and CIN
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 40132819Ng XR, Quek IP, Pereira MJ, Molina JA, Ngeow J, Wong SKW. Randomised controlled trial evaluating the impact of different methods of HPV DNA testing for cervical cancer screening in Singapore's primary care settings: a study protocol. BMJ Open. 2025 Mar 24;15(3):e095091. doi: 10.1136/bmjopen-2024-095091.
- 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.
Ng Xin Rong, MBBS principal investigator
National Healthcare Group Polyclinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampled HPV DNA testing and Clinician-sampled HPV DNA test in people with Uterine Cervical Neoplasms, run by National Healthcare Group Polyclinics at 1 site in Singapore.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ng Xin Rong, MBBS (+65 63553000, xin_rong_ng@nhgp.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of high-risk Human Papillomavirus (HPV) DNA (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528184, which also lists 1 linked publication.
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 10 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.