Prognostic Study of HPV Virus Integration in Women With HSIL

Fujian Maternity and Child Health Hospital

Status: Enrolling

Conditions: Virus Integration; HPV Infection; HSIL, High Grade Squamous Intraepithelial Lesions

Treatments: Other: Follow up

Study type: Observational

Funder types: Other

Identifiers

NCT05745597

HINH2301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive cancer;
• No surgical treatment or conization only;
• Obtain informed consent.

Exclusion criteria

• During pregnancy or lactation;
• Patients with a history of genital tract cancer;
• Previous history of hysterectomy, cervical surgery or pelvic radiotherapy;
• Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month;
• Use of antibiotics or vaginal microecological improvement products in the past 1 month.

Trial design

1,000 participants in 1 patient group

HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology

Description:

In this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24.

Treatment:

Other: Follow up