Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study.
Yuhang Zhang, Yan Zhang, Ting Hu...
https://pubmed.ncbi.nlm.nih.gov/40295124Actively Recruiting
Age: 0 - 45Years
FEMALE
ID05282095
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China
Led by Fujian Maternity and Child Health Hospital · Updated on 2024-09-19
300
Participants Needed
20
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of HPV integration in predicting the prognosis of young women aged 45 and below diagnosed with cervical intraepithelial neoplasia grade 2 (CIN2), a precancerous cervical condition. The study aims to explore the correlation between HPV integration, vaginal flora changes, and cervical cytology results to better understand disease progression and outcomes. This multi-center cohort study includes 300 participants from hospitals in China, focusing on the natural course of CIN2 without surgical or medication treatment when appropriate. Participants will be followed at enrollment and then at 3, 6, 9, and 12 months. At these visits, HPV viral integration tests, HPV genotyping tests, cervical cytology, and sequencing of vaginal secretions will be performed. Colposcopies and biopsies will be conducted at 6 and 12 months to closely monitor cervical tissue changes. The study observes participants under regular clinical follow-up without intervention unless disease progression occurs. During the study, participants will provide cervical secretions and exfoliated cell samples for testing. Researchers will assess cervical histopathology, HPV integration status, cervical cytology, vaginal flora diversity, and HPV genotyping at multiple time points. Outcomes measured include cervical tissue changes and HPV-related markers to evaluate the disease's natural course. The study lasts 12 months with scheduled clinical visits and laboratory assessments to monitor participants' cervical health and HPV status throughout this period.
CONDITIONS
Brief Title
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
Who Can Participate
Age: 0 - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female, aged 18 years or older and 45 years or younger, with a desire to conceive
- Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) by cervical biopsy within the past 3 months
- No prior cervical surgery, physical, or medication treatment for the condition
- Lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months
- Plans to undergo 12-month follow-up observation without treatment if disease does not progress
- Understands and voluntarily agrees to participate and signs informed consent
You will not qualify if you...
- Cervical status showing Type III transformation zone at enrollment as determined by colposcopy within past 3 months
- Pregnant or lactating women
- History of malignant tumors in the reproductive tract
- History of hysterectomy, cervical surgery, or pelvic radiation therapy
- Received physical therapy to the cervix within 24 months prior to enrollment
- 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 (can re-enroll after 3 days)
- Sexual intercourse within 24 hours prior to sampling (can re-enroll after 24 hours)
- Treatment for genital tract infections, HPV, or other STDs within past month (can re-enroll after 1 month)
- Use of antibiotics or vaginal microecological products within past month (can re-enroll after 1 month)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 12 months
Participants are observed with tests including HPV viral integration, HPV genotyping, cervical cytology, and vaginal secretion analysis to evaluate the progression of CIN2.
5 visits at baseline, 3, 6, 9, and 12 months
Diagnostic Evaluation
Duration - 12 months
Colposcopies and biopsies are performed to assess cervical histopathology at 6 and 12 months.
2 visits at 6 and 12 months
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
P
Pengming Sun
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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