Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine
NCT06261892
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
Eligibility
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.
Conditions2
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NCT06261892