NCT05745597

Prognostic Study of HPV Virus Integration in Women With HSIL

Prognostic Study of Different HPV Virus Integration in Women With HSIL

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Fujian Maternity and Child Health Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-09-30
• Completion: 2025-10-31
• First posted: 2023-02-27
• Last updated: 2023-02-27

Locations

13 sites across 1 country: China