Effect of HPV Integration on Prognosis of Young Women With CIN2 in China

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282095
• Other study ID #: HPVZHCIN22021
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2023
• Source: Fujian Maternity and Child Health Hospital
• Contact: Binhua Dong
• Phone: +86-591-87558732
• Email: dbh18-jy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.

Description:

This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 45 Years

Eligibility

Inclusion Criteria:

• Women =45 years of age with a sexual history.

• Young woman with histopathologically confirmed CIN2.

• No history of cervical conization or total hysterectomy, etc.

• No sexual experience, vaginal medication or drug flushing within 72 hours before sampling.

Exclusion Criteria:

• Pregnant and lactating women.

• Patients with history of genital tract tumor.

• History of HPV vaccination.

• Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.

• In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.

• Use antibiotics or vaginal microecological improvement products in recent 1 month.

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• HPV Infection
• HSIL, High Grade Squamous Intraepithelial Lesions
• Papillomavirus Infections
• Uterine Cervical Dysplasia

Intervention

Other:
• Follow up
Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up.

Locations

Country	Name	City	State
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guiyang maternal and child health care hospital	Guiyang	Guizhou
China	Gansu Provincial Maternal and Child Health Care Hospital	Lanzhou	Gansu
China	Longyan First Hospital	Longyan	Fujian
China	Longyan People Hospital of Fujian	Longyan	Fujian
China	The Second Hospital of Longyan	Longyan	Fujian
China	Jiangxi maternal and Child Health Hospital	Nanchang	Jiangxi
China	Nanping Second Hospital	Nanping	Fujian
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Mindong Hospital of Ningde City	Ningde	Fujian
China	Ningde Municipal Hospital of Ningde Normal University	Ningde	Fujian
China	The Affiliated Hospital of Putian University	Putian	Fujian
China	The First Hospital of Putian City	Putian	Fujian
China	Quanzhou First Hospital Afflicated to Fujian Medical University	Quanzhou	Fujian
China	Sanming Second Hospital	Sanming	Fujian
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai
China	Shenzhen Maternity and Child HealthCare Hospital	Shenzhen	Guangdong
China	Hubei Maternal and Child Health Care Hospital	Wuhan	Hubei
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Northwest Women's and Children's Hospital	Xi'an	Shanxi
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Zhangzhou affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical histopathology testing at baseline	Cervical histopathology was performed at baseline for all participants.	Baseline
Primary	Cervical histopathology testing at 6-month follow-up	Cervical histopathology was performed at 6-month follow-up for all participants.	6-month follow-up
Primary	Cervical histopathology testing at 12-month follow-up	Cervical histopathology was performed at 12-month follow-up for all participants.	12-month follow-up
Primary	Human Papillomavirus (HPV) viral integration test at baseline	Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.	Baseline
Primary	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
Primary	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
Primary	Cervical cytology testing at baseline	All participants were tested for cervical cytology at the time of baseline.	Baseline
Primary	Cervical cytology testing at 3-month follow-up	All participants were tested for cervical cytology at 3-month follow-up.	3-month follow-up
Primary	Cervical cytology testing at 6-month follow-up	All participants were tested for cervical cytology at 6-month follow-up	6-month follow-up
Primary	Cervical cytology testing at 9-month follow-up	All participants were tested for cervical cytology at 9-month follow-up	9-month follow-up
Primary	Cervical cytology testing at 12-month follow-up	All participants were tested for cervical cytology at 12-month follow-up	12-month follow-up
Primary	16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	Baseline
Primary	16SrRNA sequencing of the vaginal secretions at 3-month follow-up	All participants underwent vaginal secretion sequencing at 3-month follow-up.	3-month follow-up
Primary	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
Primary	16SrRNA sequencing of the vaginal secretions at 9-month follow-up	All participants underwent vaginal secretion sequencing at 9-month follow-up	9-month follow-up
Primary	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
Primary	Human Papillomavirus (HPV) genotyping tests at baseline	All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.	Baseline
Primary	Human Papillomavirus (HPV) genotyping tests at 3-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up.	3-month follow-up
Primary	Human Papillomavirus (HPV) genotyping tests at 9-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up.	9-month follow-up