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Prognostic Study of HPV Virus Integration in Women With HSIL

NCT05745597 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-02-27

No results posted yet for this study

Summary

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.

Conditions

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

Interventions

OTHER

Follow up

Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.

Sponsors & Collaborators

  • Fujian Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • Pengming Sun · Fujian Maternal and Child Health Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-09-30
Completion
2025-10-31

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 NCT05745597 on ClinicalTrials.gov