Cervical CancerNCT06261892
Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine
A study testing Collect HPV DNA from urine in people with Cervical Cancer, run by WomenX Biotech Limited at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is 1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer. 2. If HPV DNA 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
- What is being tested?
- Collect HPV DNA from urine
- 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
- Recruiting
WomenX Biotech Limited
Hong Kong
Alan LIU, Master, +852 64786939, alanliu@womenx.net
About this study
The goal of this clinical trial is
- To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.
- If HPV DNA is not a promising biomarker, other biomarkers will be explored.
- To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.
Read more
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
- Join the briefing session of the study
- Sign the consent form and health questionnaire
- Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
- Collect the urine 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 HPV DNA from urine 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 urine sample to us with a unique identifier number given.
- Conditions
- Cervical Cancer
- Being tested
- Collect HPV DNA from urine
- Keywords
- pre-cervical cancer, cervical cancer, CIN, Sanitary pad, non-invasive detection method, HPV
- 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.
Collect HPV DNA from urineDiagnostic test
Use a sample collector to collect urine
| Study group | Role | What they receive |
|---|---|---|
| Collect HPV DNA from urine | Experimental | Not described Receives: Diagnostic Test: Collect HPV DNA from urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
- First posted15 Feb 2024
- Study start20 Jul 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- WomenX Biotech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hong Kong Science and Technology Parks Corporation
- Responsible party
- Principal investigator, Pui Wah Choi, WomenX Biotech Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261892
- Sponsor's protocol ID
- 2023-002
- 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 30207593Teame 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 29352278Aoki 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 32266804Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine
- ClinicalTrials.gov ID
- NCT06261892
- Acronym / sponsor ID
- 2023-002
- Conditions
- Cervical Cancer
- Keywords
- pre-cervical cancer, cervical cancer, CIN, Sanitary pad, non-invasive detection method, HPV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- WomenX Biotech LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hong Kong Science and Technology Parks Corporation
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is
- To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.
- If HPV DNA is not a promising biomarker, other biomarkers will be explored.
- To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.
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
- Join the briefing session of the study
- Sign the consent form and health questionnaire
- Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
- Collect the urine 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 HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer
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 urine sample to us with a unique identifier number given.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collect HPV DNA from urine | Experimental | Diagnostic Test: Collect HPV DNA from urine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect HPV DNA from urineUse a sample collector to collect urine | Diagnostic test | Collect HPV DNA from urine |
Primary outcome
HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer
Time frame: From enrollment to sample analysis, 1month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 29352278Teame 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.
- Background: PubMed 32266804Aoki 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.
- Background: PubMed 25956407Wang 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 CancerLink provided by the sponsor.
- Cervical Cancer: StatisticsLink provided by the sponsor.
- Cervical Cancer: Screening and Prevention. Doctor-Approved Patient Information from ASCOLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collect HPV DNA from urine in people with Cervical Cancer, 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?
HPV DNA from urine 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 NCT06261892, 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.