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

NCT05283239 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-11-18

No results posted yet for this study

Summary

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.

Conditions

  • HPV Infection
  • LSIL, Low-Grade Squamous Intraepithelial Lesions
  • HSIL, High-Grade Squamous Intraepithelial Lesions
  • Virus Integration

Interventions

OTHER

Follow up

Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.

Sponsors & Collaborators

  • Fujian Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • Binhua Dong, MD · Fujian Maternity and Child Health Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283239 on ClinicalTrials.gov