AzTrials
AzTrials

Cervical CancerNCT06261879

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

A study testing Special sanitary pad in people with Cervical Cancer and CIN, run by WomenX Biotech Limited at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer, CIN
What is being tested?
Special sanitary pad
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteHong Kong
Study dates
20 Jul 2023to Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting

  • WomenX Biotech Limited

    Hong Kong

    Alan LIU, Master, +852 64786939, alanliu@womenx.net

    Recruiting

Other trials in Hong Kong

About this study

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.
Read more

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

Read the 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 menstrual blood to us with a unique identifier number given.

Conditions
Cervical Cancer, CIN
Being tested
Special sanitary pad
Keywords
pre-cervical cancer, cervical cancer, CIN, Sanitary pad, non-invasive detection method, pap smear test
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Special sanitary padDevice

    The special sanitary pad is similar to the normal sanitary pad with 0.01 agar gel only. The agar gel is an approved source of food.

Study groups in NCT06261879
Study groupRoleWhat they receive
A sanitary pad as a menstrual blood collectorExperimentalThe sanitary pad is similar to the normal sanitary pad.
Receives: Device: Special sanitary pad

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Hemoglobin will be depleted from samples using NTA agarose beads according to the method of Ringrose and following the manufacturer's instructions [1]. A human ACTN4 ELISA kit (Cusabio Biotech Co. LTD) will be used according to the manufacturer's instructions for revealing the concentration of ACTN4 in the samples [2].

    1. Ringrose, J.H., et al., Highly efficient depletion strategy for the two most abundant erythrocyte soluble proteins improves proteome coverage dramatically. J Proteome Res, 2008. 7(7): p. 3060-3.
    2. ELISA Protocol-Cusabio. Cusabio Life Science-Your Biology Science Partner. 2020 Jul 22; Available from: https://www.cusabio.com/m-264.html.

    Measured: From enrollment to sample analysis, 1month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start20 Jul 2023
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261879
Sponsor's protocol ID
2023-001
Status last verified
Feb 2024
First submitted
7 Feb 2024
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Teame H, Addissie A, Ayele W, Hirpa S, Gebremariam A, Gebreheat G, Jemal A. Factors associated with cervical precancerous lesions among women screened for cervical cancer in Addis Ababa, Ethiopia: A case control study. PLoS One. 2018 Jan 19;13(1):e0191506. doi: 10.1371/journal.pone.0191506. eCollection 2018.

    PubMed 29352278

  • Aoki ES, Yin R, Li K, Bhatla N, Singhal S, Ocviyanti D, Saika K, Suh M, Kim M, Termrungruanglert W. National screening programs for cervical cancer in Asian countries. J Gynecol Oncol. 2020 May;31(3):e55. doi: 10.3802/jgo.2020.31.e55. Epub 2020 Feb 26.

    PubMed 32266804

  • Wang B, He M, Chao A, Engelgau MM, Saraiya M, Wang L, Wang L. Cervical Cancer Screening Among Adult Women in China, 2010. Oncologist. 2015 Jun;20(6):627-34. doi: 10.1634/theoncologist.2014-0303. Epub 2015 May 8.

    PubMed 25956407

Questions about this trial

What is this clinical trial studying?

A study testing Special sanitary pad in people with Cervical Cancer and CIN, run by WomenX Biotech Limited at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACTN4 is a promising biomarkers for the detection of pre-cervical/ cervical cancer (time frame: From enrollment to sample analysis, 1month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06261879, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in