Prognostic Study of HPV Virus Integration in Women With HSIL

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prognostic Study of Different HPV Virus Integration in Women With HSIL

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

Intervention / Treatment
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* Other: Follow up


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology<br>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. | Other: Follow up<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical cytology testing at baseline | All participants were tested for cervical cytology at the time of baseline. | Baseline | 
| Cervical cytology testing at 6-month follow-up | All participants were tested for cervical cytology at 6-month follow-up for all participants. | 6-month follow-up | 
| Cervical cytology testing at 12-month follow-up | All participants were tested for cervical cytology at 12-month follow-up | 12-month follow-up | 
| Cervical cytology testing at 24-month follow-up | Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 24-month follow-up | 24-month follow-up | 
| 16SrRNA sequencing of the vaginal secretions at baseline | All participants underwent vaginal secretion sequencing at baseline. | Baseline | 
| 16SrRNA sequencing of the vaginal secretions at 6-month follow-up | All participants underwent vaginal secretion sequencing at 6-month follow-up | 6-month follow-up | 
| 16SrRNA sequencing of the vaginal secretions at 12-month follow-up | All participants underwent vaginal secretion sequencing at 12-month follow-up | 12-month follow-up | 
| 16SrRNA sequencing of the vaginal secretions at 24-month follow-up | All participants underwent vaginal secretion sequencing at 24-month follow-up | 24-month follow-up | 
| Human Papillomavirus (HPV) viral integration test at baseline | Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants. | Baseline | 
| Human Papillomavirus (HPV) viral integration test at 6-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants. | 6-month follow-up | 
| Human Papillomavirus (HPV) viral integration test at 12-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants. | 12-month follow-up | 
| Human Papillomavirus (HPV) viral integration test at 24-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants. | 24-month follow-up | 
| Human Papillomavirus (HPV) genotyping tests at baseline | All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline. | Baseline | 
| Human Papillomavirus (HPV) genotyping tests at 6-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up. | 6-month follow-up | 
| Human Papillomavirus (HPV) genotyping tests at 12-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up. | 12-month follow-up | 
| Human Papillomavirus (HPV) genotyping tests at 24-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up. | 24-month follow-up |