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The goal of this clinical trial is
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
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A sanitary pad as a menstrual blood collector | Experimental | The sanitary pad is similar to the normal sanitary pad. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Special sanitary pad | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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].
| From enrollment to sample analysis, 1month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WomenX Biotech Limited | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | 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. | |
| 29352278 | Background | 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. |
| Label | URL |
|---|---|
| Cervical Cancer | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 32266804 | Background | 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. |
| 25956407 | Background | 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. |
| Cervical Cancer: Statistics | View source |
| Cervical Cancer: Screening and Prevention. Doctor-Approved Patient Information from ASCO | View source |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |