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

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

NCT ID: NCT06261892

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
pre-cervical cancer
cervical cancer
CIN
Sanitary pad
non-invasive detection method
HPV

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Collect HPV DNA from urine
Description: Use a sample collector to collect urine
Arm group label: Collect HPV DNA from urine

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

Detailed description: First stage of study: Female subjects within the age group will first attend an online research briefing session. After the online briefing session, the participant is provided an opportunity to join a private 1-to-1 consultation session, which enables the participant to be more familiar with the details of the research content, consent form, study procedures, and data confidentiality. If they have no further questions regarding the research content, consent form, etc. during the consultation session. They will sign the consent for participating in the study, they will fill in a questionnaire (attached) and clinic pap smear application form (attached). The questionnaire helps the research team to understand the subject's medical, gynaecological, and sexual histories; a unique identifier code will be given to each subject. Second Stage of study: The research team will select the subjects based on the questionnaire answers. If the selected subjects have undergone pap test/ HPV test or coloscopy recently, within 3 months, they will submit the related medical record with the unique identifier number to us. If the selected subjects have not undergone pap test/ HPV test or coloscopy recently, within 3 months, they will be sponsored to Pap test or/and HPV genotyping or/and colposcopy at the designated hospitals or clinics. When their Pap test or/and HPV genotyping or/and colposcopy results are available, they or the designated hospitals/ clinics will send us the related medical reports with the unique identifier number. Third Stage of Study: The participants will be further selected according to the medical records submitted. If the participants were selected to enter the third stage of the study, the selected subjects will submit their urine sample to us with a unique identifier number given.

Criteria for eligibility:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: WomenX Biotech Limited

Address:
City: Hong Kong
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Alan LIU, Master

Phone: +852 64786939
Email: alanliu@womenx.net

Start date: July 20, 2023

Completion date: June 2025

Lead sponsor:
Agency: WomenX Biotech Limited
Agency class: Industry

Collaborator:
Agency: Hong Kong Science and Technology Parks Corporation
Agency class: Other

Source: WomenX Biotech Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06261892
https://www.who.int/health-topics/cervical-cancer
https://www.cancer.net/cancer-types/cervical-cancer/statistics.
https://www.cancer.net/cancer-types/cervical-cancer/screening-and-prevention.