Cervical Cancer ScreeningNCT07468578
Community Implementation of Urine HPV Test and Reflex DNA Methylation Test in Cervical Cancer Screening
An observational study of Cervical Cancer Screening, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Aims: The project aims to explore the acceptability and feasibility of a self-sampling, urine-based HPV test (INDICAID HPV Urine Test) in a community setting, and the effectiveness of DNA methylation test for triaging high-risk HPV (HR-HPV) positive women to colposcopy examination compared to the current standard… Read more about this study
- Who is it for?
- Ages 26 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- How many people
- 8,620 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2026to Mar 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 26 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), District Health Centers, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations and online.
Who may be able to join
- Women aged 26-65
- History of sexual activity
Who cannot join
- Pregnancy
- History of total hysterectomy
- History of cervical cancer
- Currently under treatment for cervical dysplasia or cervical cancer
- Unwilling to participate in the study
- Cannot give written consent to the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Department of Obstetrics and Gynaecology, the University of Hong Kong
Hong Kong
Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK), 852-22554265, kklchan@hku.hk
Tina WEI, PhD, 852-22554265, tinawei@hku.hk
About this study
Aims:
The project aims to explore the acceptability and feasibility of a self-sampling, urine-based HPV test (INDICAID HPV Urine Test) in a community setting, and the effectiveness of DNA methylation test for triaging high-risk HPV (HR-HPV) positive women to colposcopy examination compared to the current standard triage methods of cytology and HPV16/18 genotyping.
Read more
There are two main hypotheses:
- Urine self-sampling for HPV testing is an acceptable cervical screening option for women in the community.
- Combining urine HPV testing with DNA methylation will increase the detection rate of high-grade lesions without increasing the colposcopy referral rate.
Target participants:
Women between the ages of 26-65 and have a history of sexual activity, not have a history of total hysterectomy or cervical cancer, not currently pregnant, not currently under treatment of cervical dysplasia or cervical cancer.
This is a prospective study and women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), public areas in Queen Mary Hospital (such as lobby of out-patient clinics and corridors), District Health Centres, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations, and online.
A total of 8,620 women are needed to be recruited to the study: approximately 4,700 onsite and 4,000 online.
Study procedures:
Self-collected urine samples from study subjects recruited in various communities will be examined using the INDICAID HPV Urine Test. Women with positive urine HPV results will undergo further testing, including urine DNA methylation and co-testing (cytology and HPV genotyping). They will be triaged to colposcopy when test results show clinical indications. The acceptability and feasibility of the urine test will be assessed by calculating the self-sample uptake rate and analyzing participant-reported questionnaires. The detection rate of high-grade lesions and the colposcopy referral rate will be compared between DNA methylation testing and the current standard methods.
- Conditions
- Cervical Cancer Screening
- Keywords
- urine HPV test, Cervical cancer screening, triage, methylation, self-sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the effectiveness of urine self-sample HPV test as screening tool in cervical cancer screening
Comparison of high-grade squamous intraepithelial lesion (HSIL) detection rate and colposcopy referral rate by different triaging methods: cytology, HPV16/18 genotyping or DNA methylation test.
Measured: through study completion, an average of 18 months
Secondary outcomes (2)
To explore the feasibility of urine self-sample HPV test in community application
Uptake rate of the urine self-sample HPV test (calculated by the number of samples returned/the number of self-samples bottle distributed).
Measured: 15 months
To explore the acceptability of urine self-sample HPV test in community application
Acceptability of the urine self-sample HPV test in cervical cancer screening by questionnaires survey
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 8,620 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong, Phase Scientific International Limited
- Responsible party
- Principal investigator, Karen Kar Loen CHAN, The University of Hong Kong
- Investigators
- Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK), Principal investigator, Department of Obstetrics and Gynaecology, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468578
- Sponsor's protocol ID
- UW24-382
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Implementation of Urine HPV Test and Reflex DNA Methylation Test in Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT07468578
- Acronym / sponsor ID
- UW24-382
- Conditions
- Cervical Cancer Screening
- Keywords
- urine HPV test, Cervical cancer screening, triage, methylation, self-sampling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,620 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong, Phase Scientific International Limited
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Mar 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.
Aims:
The project aims to explore the acceptability and feasibility of a self-sampling, urine-based HPV test (INDICAID HPV Urine Test) in a community setting, and the effectiveness of DNA methylation test for triaging high-risk HPV (HR-HPV) positive women to colposcopy examination compared to the current standard triage methods of cytology and HPV16/18 genotyping.
There are two main hypotheses:
- Urine self-sampling for HPV testing is an acceptable cervical screening option for women in the community.
- Combining urine HPV testing with DNA methylation will increase the detection rate of high-grade lesions without increasing the colposcopy referral rate.
Target participants:
Women between the ages of 26-65 and have a history of sexual activity, not have a history of total hysterectomy or cervical cancer, not currently pregnant, not currently under treatment of cervical dysplasia or cervical cancer.
This is a prospective study and women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), public areas in Queen Mary Hospital (such as lobby of out-patient clinics and corridors), District Health Centres, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations, and online.
A total of 8,620 women are needed to be recruited to the study: approximately 4,700 onsite and 4,000 online.
Study procedures:
Self-collected urine samples from study subjects recruited in various communities will be examined using the INDICAID HPV Urine Test. Women with positive urine HPV results will undergo further testing, including urine DNA methylation and co-testing (cytology and HPV genotyping). They will be triaged to colposcopy when test results show clinical indications. The acceptability and feasibility of the urine test will be assessed by calculating the self-sample uptake rate and analyzing participant-reported questionnaires. The detection rate of high-grade lesions and the colposcopy referral rate will be compared between DNA methylation testing and the current standard methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 26 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), District Health Centers, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations and online.
Key inclusion criteria (2 listed)
- Women aged 26-65
- History of sexual activity
Key exclusion criteria (6 listed)
- Pregnancy
- History of total hysterectomy
- History of cervical cancer
- Currently under treatment for cervical dysplasia or cervical cancer
- Unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To explore the effectiveness of urine self-sample HPV test as screening tool in cervical cancer screening
Time frame: through study completion, an average of 18 months
Comparison of high-grade squamous intraepithelial lesion (HSIL) detection rate and colposcopy referral rate by different triaging methods: cytology, HPV16/18 genotyping or DNA methylation test.
2 secondary outcomes
To explore the feasibility of urine self-sample HPV test in community application
Time frame: 15 months
To explore the acceptability of urine self-sample HPV test in community application
Time frame: 15 months
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 12 Mar 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.
Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK) principal investigator
Department of Obstetrics and Gynaecology, the University of Hong Kong
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 Cervical Cancer Screening, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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: opening soon, as of the sponsor's last update on 12 Mar 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 Hong Kong. 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 Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK) (852-22554265, kklchan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the effectiveness of urine self-sample HPV test as screening tool in cervical cancer screening (time frame: through study completion, an average of 18 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 12 Mar 2026.