Non-invasive detection of cervical cancer using urine biomarkers
Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine
This study is testing if urine samples can help detect cervical cancer in women aged 18 to 65 by looking for HPV DNA and other markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | WomenX Biotech Limited Industry-sponsored |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06261892 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the sensitivity and specificity of detecting pre-cervical and cervical cancer through HPV DNA found in urine samples. If HPV DNA proves ineffective, the study will explore alternative biomarkers for non-invasive detection. Female participants aged 18 to 65 who have menstruation will undergo a briefing session, provide consent, and submit medical records or undergo necessary tests. The study will compare results from participants with cervical conditions to those without to validate the effectiveness of urine-based biomarkers.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 65 who have menstruation and have had sexual intercourse.
Not a fit: Patients with visible signs of gynecological infections or those currently taking medication will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection of cervical cancer, improving patient outcomes.
How similar studies have performed: Other studies have explored non-invasive biomarker detection methods, but this specific approach using urine for HPV DNA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female aged between 18 to 65 * Have menstruation * Had sex before * Can read and write Chinese/ English * Without taking any medication (Except nutritional supplements, traditional Chinese medicine, and health care products etc.) Exclusion Criteria: • Subjects who used medication will be excluded from the sample collection. Moreover, subjects with visible signs of gynarcological infections (e.g. gonorrhea, trichomonas vaginalis) or suffered an HIV/ hepatitis B virus (HBV)-infection will be excluded.
Where this trial is running
Hong Kong
- WomenX Biotech Limited — Hong Kong, Hong Kong (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.