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Postmenopausal Women With Vaginal Microbiota

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ClinicalTrials.gov Identifier: NCT03786601
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
shuwang, Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment
HPV-Related Squamous Cell Carcinoma Other: Observation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women
Estimated Study Start Date : December 25, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Group/Cohort Intervention/treatment
Group A,
High-risk HPV infection in postmenopausal women
Other: Observation
The participants were assigned to different groups according to the results of HPV detection.

Group B
High-risk HPV negative in postmenopausal women
Group C
High-risk HPV infection in gestational women
Other: Observation
The participants were assigned to different groups according to the results of HPV detection.

Group D
High-risk HPV negative in gestational women



Primary Outcome Measures :
  1. Vaginal microbiota and HR-HPV infection in menopausal women [ Time Frame: 6 months ]
    The persistence vaginal organism in HPV infection menopausal women


Secondary Outcome Measures :
  1. The difference of vaginal microbiota in different age groups [ Time Frame: 6 months ]
    The difference of vaginal microbiota in different age groups with HR-HPV infection

  2. The difference of vaginal microbiota in different age groups [ Time Frame: 6 months ]
    The difference of vaginal microbiota in different age groups without HR-HPV



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
The participants sample was referred to the paper already published.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Additional Information:

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Responsible Party: shuwang, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03786601     History of Changes
Other Study ID Numbers: PMWVM
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell