NCT06261892

Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine

WomenX Biotech Limited·ClinicalTrials.gov·diagnostic testRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Cervical Cancer
Drug/Device/Intervention
Collect HPV DNA from urine
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
WomenX Biotech Limited
Location
Hong Kong, China
Timeline & enrollment
Phase
N/A
Start date
Jul 20, 2023
End date
Jun 01, 2025
Enrollment
300 participants
Primary outcome

HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer

Summary

The goal of this clinical trial is
 
 1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of
 pre-cervical or/and cervical cancer.
 
 2. If HPV DNA is not a promising biomarker, other biomarkers will be explored.
 
 3. To develop an effective and non-invasive detection method of the pre-cervical or/and
 cervical cancer. in Women with menstruation.
 
 The main question it aims to answer is:
 
 To validate whether HPV DNA from urine could be used as a non-invasive means for the
 detection of pre-cervical or cervical cancer
 
 Participants will
 
 1. Join the briefing session of the study
 
 2. Sign the consent form and health questionnaire
 
 3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear
 test
 
 4. Collect the urine sample
 
 If there is a comparison group: Researchers will compare The diseased group and the healthy
 group according to the medical reports they provided to see if HPV DNA from urine is a
 promising biomarker for the detection of pre-cervical or cervical cancer

ICD-10 classifications
Severe cervical dysplasia, not elsewhere classifiedMild cervical dysplasiaModerate cervical dysplasiaCarcinoma in situ: Cervix, unspecifiedCervical root disorders, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06261892
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06261892 through Pure Global AI's free database. This phase not specified trial is sponsored by WomenX Biotech Limited and is currently Recruiting. The study focuses on Cervical Cancer. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.