HPV-Related Squamous Cell CarcinomaNCT03786601
Postmenopausal Women With Vaginal Microbiota
An observational study of HPV-Related Squamous Cell Carcinoma, 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 in postmenopausal women. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- HPV-Related Squamous Cell Carcinoma
- What is being tested?
- Observation
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2018to 1 Jul 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 20 to 75 years
- Women only
- Adult, Older adult
Study population: The participants sample was referred to the paper already published.
Who may be able to join
- Those are aged 20 to 75 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
Who cannot join
- Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hui Xu, +86-010-69156874
About this study
Official title: High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women
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 in postmenopausal women.
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. Owing to the decrease of estrogen level and cervical atrophy in postmenopausal women, cervical cytology is more prone to abnormal changes than in premenopausal women. Clinically, cervical lesions in elderly women are easily neglected. Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor prognosis and more complications of treatment. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in menopausal women. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.
- Conditions
- HPV-Related Squamous Cell Carcinoma
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The participants were assigned to different groups according to the results of HPV detection.
| Study group | Role | What they receive |
|---|---|---|
| Group A, | High-risk HPV infection in postmenopausal women Receives: Other: Observation | |
| Group B | High-risk HPV negative in postmenopausal women | |
| Group C | High-risk HPV infection in gestational women Receives: Other: Observation | |
| Group D | High-risk HPV negative in gestational women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal microbiota and HR-HPV infection in menopausal women
The persistence vaginal organism in HPV infection menopausal women
Measured: 6 months
Secondary outcomes (2)
The difference of vaginal microbiota in different age groups
The difference of vaginal microbiota in different age groups with HR-HPV infection
Measured: 6 months
The difference of vaginal microbiota in different age groups
The difference of vaginal microbiota in different age groups without HR-HPV
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start25 Dec 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Squamous Cell CarcinomaStudies 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
- 1 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
- NCT03786601
- Sponsor's protocol ID
- PMWVM
- Status last verified
- Aug 2019
- First submitted
- 21 Dec 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03786601
- Acronym / sponsor ID
- PMWVM
- Conditions
- HPV-Related Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 26 Dec 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 in postmenopausal women.
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. Owing to the decrease of estrogen level and cervical atrophy in postmenopausal women, cervical cytology is more prone to abnormal changes than in premenopausal women. Clinically, cervical lesions in elderly women are easily neglected. Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor prognosis and more complications of treatment. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in menopausal women. 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A, | – | Other: ObservationHigh-risk HPV infection in postmenopausal women |
| Group B | – | –High-risk HPV negative in postmenopausal women |
| Group C | – | Other: ObservationHigh-risk HPV infection in gestational women |
| Group D | – | –High-risk HPV negative in gestational women |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The participants sample was referred to the paper already published.
Key inclusion criteria (1 listed)
- Those are aged 20 to 75 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
Key exclusion criteria (1 listed)
- Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
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 |
|---|---|---|
| ObservationThe participants were assigned to different groups according to the results of HPV detection. | Other | Group A,, Group C |
Primary outcome
Vaginal microbiota and HR-HPV infection in menopausal women
Time frame: 6 months
The persistence vaginal organism in HPV infection menopausal women
2 secondary outcomes
The difference of vaginal microbiota in different age groups
Time frame: 6 months
The difference of vaginal microbiota in different age groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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 HPV-Related Squamous Cell Carcinoma, 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 29 Aug 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?
Contact Shu Wang (+86-18810535568, chaoxp_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal microbiota and HR-HPV infection in menopausal women (time frame: 6 months). 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 29 Aug 2019.