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Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine - Trial NCT06261892

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.

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NCT06261892
Recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06261892
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Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine

Study Focus

Cervical Cancer

Collect HPV DNA from urine

Interventional

diagnostic test

Sponsor & Location

WomenX Biotech Limited

Hong Kong, China

Timeline & Enrollment

N/A

Jul 20, 2023

Jun 01, 2025

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 classified
Mild cervical dysplasia
Moderate cervical dysplasia
Carcinoma in situ: Cervix, unspecified
Cervical root disorders, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT06261892

Non-Device Trial