UnknownNot Applicable

Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood

Hong Kong300 participantsStarted 2023-07-20

Plain-language summary

The goal of this clinical trial is 1. To test the sensitivity and specificity of using ACTN4 from menstrual blood for the detection of pre-cervical or/and cervical cancer. 2. If ACTN4 is not a promising biomarker, other biomarkers will be explored. 3. To develop an effective and non-invasive detection method for pre-cervical or/and cervical cancer. in Women with menstruation. The main question it aims to answer is: To validate whether menstrual blood 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 menstrual blood 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 ACTN4 from menstrual blood is a promising biomarker for the detection of pre-cervical or cervical cancer

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ACTN4 is a promising biomarkers for the detection of pre-cervical/ cervical cancer

Timeframe: From enrollment to sample analysis, 1month

Trial details

NCT IDNCT06261879

SponsorWomenX Biotech Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06

View on ClinicalTrials.gov More Cervical Cancer trials