Cervical Cancer Clinical Trial
Official title:
Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood
NCT number | NCT06261879 |
Other study ID # | 2023-001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 20, 2023 |
Est. completion date | June 2025 |
Verified date | February 2024 |
Source | WomenX Biotech Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | WomenX Biotech Limited | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
WomenX Biotech Limited |
Hong Kong,
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. — View Citation
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. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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].
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. ELISA Protocol-Cusabio. Cusabio Life Science-Your Biology Science Partner. 2020 Jul 22; Available from: https://www.cusabio.com/m-264.html. |
From enrollment to sample analysis, 1month |
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