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

NCT05282095 · tracked via the Priya Life Science China tracker

Sponsor

Fujian Maternity and Child Health Hospital

Phase

Observational

Started

2022-06-01

Last updated

2024-09-19

Condition(s) studied

Cervical Intraepithelial NeoplasiaHPV InfectionVirus IntegrationHSIL, High Grade Squamous Intraepithelial Lesions

Investigational drug(s) / intervention(s)

Follow up

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

—

Max age

45 Years

Healthy volunteers

Inclusion Criteria: * Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive; * Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment; * The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months; * Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress; * Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form. Exclusion Criteria: * Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone; * Pregnant or lactating; * History of malignant reproductive tract tumors; * History of hysterectomy, cervical surgery, or pelvic radiation therapy; * Physical therapy to the cervix within 24 months prior to enrollment; * The subject has a severe immune system disease that is active; * Long-term use of contraceptives within 12 months prior to enrollment; * Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation); * Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation); * Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment); * Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);

Primary outcome measure(s)

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

Trial sites (20)

Facility	City	Region	Status
Fujian Maternity and Child Health Hospital	Fuzhou	Fujian	Recruiting
Fujian Medical University Union Hospital	Fuzhou	Fujian	Recruiting
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	Recruiting
Longyan First Hospital	Longyan	Fujian	Recruiting
The Second Hospital of Longyan	Longyan	Fujian	Recruiting
Ningde Municipal Hospital of Ningde Normal University	Ningde	Fujian	Recruiting
The First Hospital of Putian City	Putian	Fujian	Recruiting
The Affiliated Hospital of Putian University	Putian	Fujian	Recruiting
Sanming Second Hospital	Sanming	Fujian	Recruiting
Zhangzhou affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian	Recruiting
Gansu Provincial Maternal and Child Health Care Hospital	Lanzhou	Gansu	Recruiting
Shenzhen Maternity and Child HealthCare Hospital	Shenzhen	Guangdong	Recruiting
Guiyang maternal and child health care hospital	Guiyang	Guizhou	Recruiting
Hubei Maternal and Child Health Care Hospital	Wuhan	Hubei	Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei	Recruiting
Zhongnan Hospital of Wuhan University	Wuhan	Hubei	Recruiting
Jiangxi maternal and Child Health Hospital	Nanchang	Jiangxi	Recruiting
Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai Municipality	Recruiting
Northwest Women's and Children's Hospital	Xi’an	Shanxi	Recruiting
The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang	Recruiting

More Fujian Maternity and Child Health Hospital trials in China

Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection Active, not recruiting

Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity Starting soon

Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors Recruiting

Other trials for the same condition

A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years Recruiting

All-cause and Diseases-specific Mortality of High-risk HPV Infection Starting soon

Immunogenicity and Safety of Sequential 2vHPV-9vHPV Vaccination in Girls Aged 9-14 Years Active, not recruiting

Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection Active, not recruiting

To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05282095 on ClinicalTrials.gov ↗ ← All trials in China