Community Implementation of Urine HPV Test and Reflex DNA Methylation Test in Cervical Cancer Screening

NCT07468578 | Not Yet Recruiting

• 1 other identifier: UW24-382
• Study Type: observational
• Target: 8,620
• Locations: 1 country
• Sites: 1

Brief 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 triage methods of cytology and HPV16/18 genotyping. There are two main hypotheses:

1. 1.Urine self-sampling for HPV testing is an acceptable cervical screening option for women in the community.
2. 2.Combining urine HPV testing with DNA methylation will increase the detection rate of high-grade lesions without increasing the colposcopy referral rate.

Conditions

Cervical Cancer Screening

Keywords

urine HPV test; Cervical cancer screening; triage; methylation; self-sampling

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 18 months

Secondary Outcomes (2)

• To explore the feasibility of urine self-sample HPV test in community application

  15 months

• To explore the acceptability of urine self-sample HPV test in community application

  15 months

Eligibility Criteria

• Age: 26 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Women aged 26-65
• History of sexual activity

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Innovation and Technology Commission, Hong Kong: collaborator
• Phase Scientific International Limited: collaborator

Study Sites (1)

Department of Obstetrics and Gynaecology, the University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine

Study Officials

• Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK)

  Department of Obstetrics and Gynaecology, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK)

CONTACT

852-22554265; kklchan@hku.hk

Tina Na Dr WEI, PhD

CONTACT

852-22554265; tinawei@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Department Chairperson

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)