Persistent Cervical HPV Infection With Clearance and Vaginal Microbiota

• ClinicalTrials.gov Identifier: NCT03895866
• Recruitment Status: Unknown
• First Posted: March 29, 2019
• Last Update Posted: August 29, 2019
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): shuwang, Peking Union Medical College Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
HPV-Related Squamous Cell Carcinoma	Other: The participants were assigned to different groups according to the results of HPV detection.

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. 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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Official Title: Clinical Study on the Relationship Between Persistent Cervical HPV Infection With Clearance and Vaginal Microbial Community
• Actual Study Start Date: April 11, 2019
• Estimated Primary Completion Date: February 11, 2020
• Estimated Study Completion Date: February 11, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Group A; High-risk HPV persistent infection more than half a year and reversion	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
Group B; High-risk HPV non-infection	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

Outcome Measures

Primary Outcome Measures :

1. The relationship between diversity of vaginal microbiota and HR-HPV persistent infection [ Time Frame: 12 months ]
   The persistent specific vaginal organism in HPV persistent infection women

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

The participants sample was referred to the paper already published.

Criteria

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.

Contacts and Locations

Contacts

Contact: Shu Wang; +86-18810535568; chaoxp_pumch@163.com

Locations

China, Beijing

Peking Union Medical College Hospital; Recruiting

Beijing, Beijing, China, 100730

Contact: Hui Xu +86-010-69156874

Sponsors and Collaborators

Peking Union Medical College Hospital

More Information

Additional Information:

• Responsible Party: shuwang, Associate Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03895866
• Other Study ID Numbers: HPV clearance
• First Posted: March 29, 2019
• Last Update Posted: August 29, 2019
• Last Verified: August 2019

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

Additional relevant MeSH terms:

Papillomavirus Infections; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections