Postmenopausal Women With Vaginal Microbiota

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.

Study Overview

• Status: Unknown
• Conditions: HPV-Related Squamous Cell Carcinoma
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Hui Xu; Phone Number: +86-010-69156874

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The participants sample was referred to the paper already published.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal microbiota and HR-HPV infection in menopausal women	The persistence vaginal organism in HPV infection menopausal women	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of vaginal microbiota in different age groups	The difference of vaginal microbiota in different age groups with HR-HPV infection	6 months
The difference of vaginal microbiota in different age groups	The difference of vaginal microbiota in different age groups without HR-HPV	6 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
• Other Study ID Numbers: PMWVM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No