Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection

Fujian Maternity and Child Health Hospital

Status: Enrolling

Conditions: Virus Integration; HPV Infection; HSIL, High-Grade Squamous Intraepithelial Lesions; LSIL, Low-Grade Squamous Intraepithelial Lesions

Treatments: Other: Follow up

Study type: Observational

Funder types: Other

Identifiers

NCT05283239

HIHP2201

Details and patient eligibility

About

Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.

Full description

This study aims to: 1) determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection. 2) determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection. 3) determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection, and its prognostic value in women with LSIL and HSIL.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non pregnant people with sexual history；
• Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
• No history of previous surgery at the cervical site.
• Asexual life, no vaginal medication or flushing before 72 hours of sampling.

Exclusion criteria

• Within 8 weeks after pregnancy or postpartum.
• Patients with history of genital tract tumor.
• History of HPV vaccination.
• Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
• In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
• Use antibiotics or vaginal microecological improvement products in recent 1 month.

Trial design

1,000 participants in 1 patient group

Women with persistent HR-HPV infection

Description:

In the enrollment, women with persistent HR-HPV infection for more than 18 months will be included in this study. All participants will be followed up at 6th month, 12th month, 18th month and 24th month after baseline of recruitment.

Treatment:

Other: Follow up