A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL

NCT05282745 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2023-11-18

No results posted yet for this study

Summary

Human papillomavirus (HPV) infection has become one of the most important health problems faced by women all over the world. A large number of studies have shown that women's cervical, vaginal and perianal precancerous lesions, related cancers, condyloma acuminatum and other sexually transmitted diseases (STD) are closely related to HPV infection. Among them, the persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. Previous studies have shown that there are significant differences in the effects of multiple HPV infection and persistent infection of different types (such as type-16, -18, -39 and -52) on different levels of cervical lesions, and there is a certain correlation between HPV load in the process of persistent infection and the degree of cervical lesions. In addition, other studies have shown that HPV-16 viral load has certain clinical significance in predicting Cin2 / CIN3 high-grade cervical lesions, and HPV viral load level is significantly different in cervical low-grade squamous intraepithelial lesion (LSIL) and cervical high-grade squamous intraepithelial lesion (HSIL). The above biological changes such as HPV infection type, quantity and proportion can promote the occurrence and development of cervical precancerous lesions and related cancers to varying degrees. It can be seen that the study of the relationship between HPV viral load and cervical lesions is of great significance for clinical disease development prediction and cervical cancer screening.

Conditions

  • HPV Infection
  • HSIL, High-Grade Squamous Intraepithelial Lesions
  • Viral Load

Interventions

OTHER

Follow-up

Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.

Sponsors & Collaborators

  • Fujian Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • Pengming Sun, PhD · Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-12-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

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 NCT05282745 on ClinicalTrials.gov