Postmenopausal Women With Vaginal Microbiota

HPV-Related Squamous Cell Carcinoma Clinical Trial

Official title:

High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786601
• Other study ID #: PMWVM
• Status: Recruiting
• Start date: December 25, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2019
• Source: Peking Union Medical College Hospital
• Contact: Shu Wang
• Phone: +86-18810535568
• Email: chaoxp_pumch[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: July 1, 2020
• Est. primary completion date: December 1, 2019
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• HPV-Related Squamous Cell Carcinoma

Intervention

Other:
• Observation
The participants were assigned to different groups according to the results of HPV detection.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal microbiota and HR-HPV infection in menopausal women	The persistence vaginal organism in HPV infection menopausal women	6 months
Secondary	The difference of vaginal microbiota in different age groups	The difference of vaginal microbiota in different age groups with HR-HPV infection	6 months
Secondary	The difference of vaginal microbiota in different age groups	The difference of vaginal microbiota in different age groups without HR-HPV	6 months