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

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

Recruiting
Female
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details
    HPV Infection
    LSIL
    Low-Grade Squamous Intraepithelial Lesions
    HSIL
    High-Grade Squamous Intraepithelial Lesions
    Virus Integration

NCT05283239

Fujian Maternity and Child Health Hospital

27 January 2024

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