Persistent Cervical HPV Infection With Clearance and Vaginal Microbiota

HPV-Related Squamous Cell Carcinoma Clinical Trial

Official title:

Clinical Study on the Relationship Between Persistent Cervical HPV Infection With Clearance and Vaginal Microbial Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03895866
• Other study ID #: HPV clearance
• Status: Recruiting
• Start date: April 11, 2019
• Est. completion date: February 11, 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 persistence infection and clearance of HPV infection.

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. High-risk HPV cervical infections are common in young, sexually active women. Most of these infections are transient and do not cause clinical symptoms. After 12-30 months of HPV infection, 70-90% of patients can be cleared naturally, but there are still a small number of patients with high-risk HPV infection can not be eliminated by itself and continue to infect, and can develop into cervical intraepithelial neoplasia, eventually progressing to invasive cervical cancer. Persistent infection of high-risk HPV is a necessary condition for the occurrence of cervical cancer and precancerous lesions. Early blocking of persistent infection of high-risk HPV and timely treatment of cervical precancerous lesions are of great significance in preventing the occurrence of cervical cancer. This project intends to study the relationship between vaginal microbial composition and persistent HPV infection, and determine the related strains and their molecular mechanisms, so as to provide new ideas and basis for its treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Those are aged 20 to 45 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

• HPV-Related Squamous Cell Carcinoma
• Papillomavirus Infections

Intervention

Other:
• The participants were assigned to different groups according to the results of HPV detection.
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	The relationship between diversity of vaginal microbiota and HR-HPV persistent infection	The persistent specific vaginal organism in HPV persistent infection women	12 months