Papillomavirus InfectionsNCT03548740
Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection
An observational study of Papillomavirus Infections, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- Human Papillomavirus
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 20 May 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Group A: HPV positive, and the participants who have not taken drugs and physical therapy in the past six months, nor have chronic diseases (such as DM), take their vaginal microorganisms (do not mention the past History issues). Group B: HPV negative in the past 12 months, taking the vaginal microorganisms.
Who may be able to join
- Clinical diagnosis of HR-HPV results.
Who cannot join
- Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Shu Wang, associated professor, +86-136-7124-6680, wangshu219@hotmail.com
About this study
Official title: Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.
Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.
Read the detailed description
Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.
- Conditions
- Papillomavirus Infections
- Being tested
- Human Papillomavirus
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human PapillomavirusBiological
women with high-risk Human Papillomavirus or not
| Study group | Role | What they receive |
|---|---|---|
| Group A | Not described Receives: Biological: Human Papillomavirus | |
| Group B | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal microbiota and HR-HPV infection
The persistence vaginal organism in HPV infection participants
Measured: 12 months
Vaginal microbiota and the cervical lesion
The cervical cytology, HPV and the vaginal microbiota were evaluated
Measured: 12 to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Sep 2018
- Primary completion20 Jan 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 151 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shuwang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548740
- Sponsor's protocol ID
- WS-1
- Status last verified
- Feb 2019
- First submitted
- 24 May 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.
- ClinicalTrials.gov ID
- NCT03548740
- Acronym / sponsor ID
- WS-1
- Conditions
- Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Jan 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 7 Jun 2018 (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.
Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.
Detailed description
Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Biological: Human Papillomavirus |
| Group B | – | – |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group A: HPV positive, and the participants who have not taken drugs and physical therapy in the past six months, nor have chronic diseases (such as DM), take their vaginal microorganisms (do not mention the past History issues). Group B: HPV negative in the past 12 months, taking the vaginal microorganisms.
Key inclusion criteria (1 listed)
- Clinical diagnosis of HR-HPV results.
Key exclusion criteria (1 listed)
- Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness
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 |
|---|---|---|
| Human Papillomaviruswomen with high-risk Human Papillomavirus or not | Biological | Group A |
Primary outcome
Vaginal microbiota and HR-HPV infection
Time frame: 12 months
The persistence vaginal organism in HPV infection participants
Vaginal microbiota and the cervical lesion
Time frame: 12 to 36 months
The cervical cytology, HPV and the vaginal microbiota were evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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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?
An observational study of Papillomavirus Infections, run by Peking Union Medical College Hospital at 1 site in China.
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 1 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 6 Feb 2019. 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 China. 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?
Vaginal microbiota and HR-HPV infection (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2019.