Actively Recruiting

Age: 0 - 45Years
FEMALE
NCT05282095

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

Led by Fujian Maternity and Child Health Hospital · Updated on 2024-09-19

300

Participants Needed

20

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 45 years who wishes to conceive
  • Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) by cervical tissue biopsy within the past 3 months
  • No cervical surgery, physical therapy, or medication treatment received
  • Lesion area under colposcopy less than 50% of total cervical area within the past 3 months
  • Plans to follow-up for 12 months without treatment if disease does not progress
  • Understands and agrees to participate in 12-month follow-up and signs informed consent
Not Eligible

You will not qualify if you...

  • Type III transformation zone on colposcopy within the past 3 months
  • Pregnant or lactating
  • History of malignant reproductive tract tumors
  • History of hysterectomy, cervical surgery, or pelvic radiation therapy
  • Received physical therapy to the cervix within 24 months prior to enrollment
  • Has active severe immune system disease
  • Long-term contraceptive use within 12 months prior to enrollment
  • Vaginal medication or irrigation within 72 hours prior to sampling
  • Sexual intercourse within 24 hours prior to sampling
  • Treatment for genital infections, HPV, or other STDs within past month
  • Used antibiotics or vaginal microecological products within past month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

2

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Actively Recruiting

3

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Actively Recruiting

4

Longyan First Hospital

Longyan, Fujian, China

Actively Recruiting

5

The Second Hospital of Longyan

Longyan, Fujian, China

Actively Recruiting

6

Ningde Municipal Hospital of Ningde Normal University

Ningde, Fujian, China, 352100

Actively Recruiting

7

The First Hospital of Putian City

Putian, Fujian, China, 351100

Actively Recruiting

8

The Affiliated Hospital of Putian University

Putian, Fujian, China

Actively Recruiting

9

Sanming Second Hospital

Sanming, Fujian, China

Actively Recruiting

10

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China, 363000

Actively Recruiting

11

Gansu Provincial Maternal and Child Health Care Hospital

Lanzhou, Gansu, China

Actively Recruiting

12

Shenzhen Maternity and Child HealthCare Hospital

Shenzhen, Guangdong, China

Actively Recruiting

13

Guiyang maternal and child health care hospital

Guiyang, Guizhou, China

Actively Recruiting

14

Hubei Maternal and Child Health Care Hospital

Wuhan, Hubei, China

Actively Recruiting

15

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Actively Recruiting

16

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Actively Recruiting

17

Jiangxi maternal and Child Health Hospital

Nanchang, Jiangxi, China

Actively Recruiting

18

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

19

Northwest Women's and Children's Hospital

Xi’an, Shanxi, China

Actively Recruiting

20

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Actively Recruiting

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Research Team

B

Binhua Dong

CONTACT

P

Pengming Sun

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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