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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Maternity and Child Health Hospital
RECRUITING
Fuzhou
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Guiyang maternal and child health care hospital
RECRUITING
Guiyang
Gansu Provincial Maternal and Child Health Care Hospital
RECRUITING
Lanzhou
Longyan First Hospital
RECRUITING
Longyan
The Second Hospital of Longyan
RECRUITING
Longyan
Jiangxi maternal and Child Health Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Ningde Municipal Hospital of Ningde Normal University
RECRUITING
Ningde
The Affiliated Hospital of Putian University
RECRUITING
Putian
The First Hospital of Putian City
RECRUITING
Putian
Sanming Second Hospital
RECRUITING
Sanming
Shanghai First Maternity and Infant Hospital
RECRUITING
Shanghai
Shenzhen Maternity and Child HealthCare Hospital
RECRUITING
Shenzhen
Hubei Maternal and Child Health Care Hospital
RECRUITING
Wuhan
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Northwest Women's and Children's Hospital
RECRUITING
Xi’an
Zhangzhou affiliated Hospital of Fujian Medical University
RECRUITING
Zhangzhou
Contact Information
Primary
Binhua Dong
dbh18-jy@126.com
+86-591-87558732
Backup
Pengming Sun
sunfemy@hotmail.com
+86-591-87558732
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 300
Treatments
Women aged from 18-45 with histopathologically confirmed CIN2
In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up four, at 3th month, 6th month, 9th month and 12th month.
Sponsors
Leads: Fujian Maternity and Child Health Hospital

This content was sourced from clinicaltrials.gov