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

Official title

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

Overview

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.

Detailed description

This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.

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.

Primary outcome measures

• Cervical histopathology testing at baseline [Time frame: Baseline]
• Cervical histopathology testing at 6-month follow-up [Time frame: 6-month follow-up]
• Cervical histopathology testing at 12-month follow-up [Time frame: 12-month follow-up]
• Human Papillomavirus (HPV) viral integration test at baseline [Time frame: Baseline]
• Human Papillomavirus (HPV) viral integration test at 6-month follow-up [Time frame: 6-month follow-up]
• Human Papillomavirus (HPV) viral integration test at 12-month follow-up [Time frame: 12-month follow-up]
• Cervical cytology testing at baseline [Time frame: Baseline]
• Cervical cytology testing at 3-month follow-up [Time frame: 3-month follow-up]
• Cervical cytology testing at 6-month follow-up [Time frame: 6-month follow-up]
• Cervical cytology testing at 9-month follow-up [Time frame: 9-month follow-up]

Eligibility criteria

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 20 centers

• Fujian Maternity and Child Health Hospital — Fuzhou
• Fujian Medical University Union Hospital — Fuzhou
• The First Affiliated Hospital of Fujian Medical University — Fuzhou
• Longyan First Hospital — Longyan
• The Second Hospital of Longyan — Longyan
• Ningde Municipal Hospital of Ningde Normal University — Ningde
• The First Hospital of Putian City — Putian
• The Affiliated Hospital of Putian University — Putian
• … and 12 more centers

Publications

• Zhang Y, Zhang Y, Hu T, Pu X, Dong B, Tuo X, Zou H, Zhang W, Lyu Q, Huang W, Xue H, Xu S, Osafo KS, Ren Y, Lin W, Su J, Huang X, Sun P. Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study. BMJ Open. 2025 Apr 28;15(4):e093863. doi: 10.1136/bmjopen-2024-093863. PMID 40295124

Identifiers

NCT: NCT05282095 · HPVZHCIN22021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗