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RECRUITING
NCT05282095

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

Sponsor: Fujian Maternity and Child Health Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

Any - 45 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2022-06-01

Completion Date

2026-05-31

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

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 (20)

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

Longyan First Hospital

Longyan, Fujian, China

The Second Hospital of Longyan

Longyan, Fujian, China

Ningde Municipal Hospital of Ningde Normal University

Ningde, Fujian, China

The First Hospital of Putian City

Putian, Fujian, China

The Affiliated Hospital of Putian University

Putian, Fujian, China

Sanming Second Hospital

Sanming, Fujian, China

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

Gansu Provincial Maternal and Child Health Care Hospital

Lanzhou, Gansu, China

Shenzhen Maternity and Child HealthCare Hospital

Shenzhen, Guangdong, China

Guiyang maternal and child health care hospital

Guiyang, Guizhou, 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

Jiangxi maternal and Child Health Hospital

Nanchang, Jiangxi, China

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Northwest Women's and Children's Hospital

Xi’an, Shanxi, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China