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Postmenopausal Women With Vaginal Microbiota

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Unknown

Conditions

HPV-Related Squamous Cell Carcinoma

Treatments

Other: Observation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 estimated patient

Sex

Female

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1 participants in 4 patient groups

Group A,
Description:
High-risk HPV infection in postmenopausal women
Treatment:
Other: Observation
Group B
Description:
High-risk HPV negative in postmenopausal women
Group C
Description:
High-risk HPV infection in gestational women
Treatment:
Other: Observation
Group D
Description:
High-risk HPV negative in gestational women

Trial contacts and locations

1

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Central trial contact

Shu Wang

Data sourced from clinicaltrials.gov

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