Clinical trial NCT05745597: Prognostic Study of HPV Virus Integration in Women With HSIL
Official title: Prognostic Study of Different HPV Virus Integration in Women With HSIL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
Virus Integration
HSIL, High Grade Squamous Intraepithelial Lesions
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive carcinoma

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical cytology testing at baseline
timeFrame: Baseline
measure: Cervical cytology testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: Cervical cytology testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: Cervical cytology testing at 24-month follow-up
timeFrame: 24-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at baseline
timeFrame: Baseline
measure: 16SrRNA sequencing of the vaginal secretions at 6-month follow-up
timeFrame: 6-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 12-month follow-up
timeFrame: 12-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 24-month follow-up
timeFrame: 24-month follow-up
measure: Human Papillomavirus (HPV) viral integration test at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) viral integration test at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) viral integration test at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) viral integration test at 24-month follow-up
timeFrame: 24-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
timeFrame: 24-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Longyan
country: China
facility: Longyan First Hospital
state: Fujian
city: Longyan
country: China
facility: Longyan People's Hospital
state: Fujian
city: Nanping
country: China
facility: Nanping Second Hospital
state: Fujian
city: Ningde
country: China
facility: Mindong Hospital of Ningde City
state: Fujian
city: Ningde
country: China
facility: Ningde City Hospital
state: Fujian
city: Putian
country: China
facility: Affiliated Hospital of Putian University
state: Fujian
city: Putian
country: China
facility: Putian First Hospital
state: Fujian
city: Sanming
country: China
facility: Sanming Second Hospital
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen Maternity and child Healthcare Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Shijiazhuang Obstetrics and Gynecology Hospital
state: Hebei
city: Wuhan
country: China
facility: Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Fujian Maternal and Child Health Hospital
name: Pengming Sun
role: STUDY_CHAIR
References: