Community Implementation of Urine HPV Test and Reflex DNA Methylation Test in Cervical Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer Screening. Basic parameters: 26 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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: 1. Urine self-sampling for HPV testing is an acceptable cervical screening option for women in the community. 2. 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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Women aged 26-65
- History of sexual activity
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- Department of Obstetrics and Gynaecology, the University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07468578 · UW24-382