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| Name | Class |
|---|---|
| Hong Kong Science and Technology Parks Corporation | UNKNOWN |
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The goal of this clinical trial is
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
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collect HPV DNA from urine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collect HPV DNA from urine | Diagnostic Test | Use a sample collector to collect urine |
|
| Measure | Description | Time Frame |
|---|---|---|
| HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer | Briefly, in order to concentrate all DNA, including cell free DNA fragments, gDNA extraction kit (Solarbio) will be used according to the manufacturer's instructions. Real time- polymerase chain reaction or multiple assays will be carried out using designed primers of HPV types. Primers for endogenous control are included to control DNA quality. | From enrollment to sample analysis, 1month |
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Inclusion Criteria:
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.
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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 |