Zhang Yuhang, Zhang Yan, Hu Ting, Pu Xiaowen, Dong Binhua, Tuo Xunyuan, Zou Huachun, Zhang Wei, Lyu Qiongying, Huang Wenrong, Xue Huifeng, Xu Shuxia, Osafo Kelvin Stefan, Ren Yuan, Lin Wenyu, Su Jue, Huang Xiaoyuan, Sun Pengming
The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen, Fujian, China.
Laboratory of Gynecologic Oncology, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, Fujian, China.
BMJ Open. 2025 Apr 28;15(4):e093863. doi: 10.1136/bmjopen-2024-093863.
Cervical cancer, a major global health concern, is primarily caused by human papillomavirus (HPV) infection. Although cervical intraepithelial neoplasia grade 2 (CIN2), a precancerous lesion, exhibits high spontaneous regression rates (50%-60%), particularly in younger women, current clinical management lacks accurate risk stratification. This study examines HPV integration status as a prognostic biomarker in women aged 18-45 diagnosed with CIN2, with the objective of developing a predictive tool for personalised therapeutic strategies and minimising overtreatment in this high-regression population.
This multicentre cohort study will be implemented across 20 tertiary Grade A hospitals in China, encompassing eastern, western, central and northern regions. It will recruit 240 CIN2 patients, collecting sociodemographic, lifestyle and medical history data via questionnaires. Clinical examinations will be performed at baseline and follow-up. Disease regression ((to cervical intraepithelial neoplasia grade 1 [CIN1] or lower)) and non-regression (persistent CIN2 or progression) will be evaluated. Prognostic factors will be analysed using Cox proportional hazards models, adjusting for confounders such as age, weight and socioeconomic status.
The cohort study protocol and informed consent procedures adhere to the Declaration of Helsinki and pertinent Chinese clinical research regulations. Ethical approval has been obtained from the Clinical Research Review Committee of the Fujian Maternal and Child Health Hospital (2022KYLLR01018) and from the participating hospitals. Written informed consent is secured from all participants prior to enrolment, with detailed information provided regarding study objectives, procedures, potential risks and benefits and participants' rights. Results will be published in peer-reviewed scientific journals, presented at academic meetings and conferences and released to the public through press releases.
ClinicalTrials.gov (NCT05282095); Pre-results.
宫颈癌是全球主要的健康问题，主要由人乳头瘤病毒（HPV）感染引起。尽管宫颈上皮内瘤变2级（CIN2）作为一种癌前病变，具有较高的自发消退率（50%-60%），尤其是在年轻女性中，但目前的临床管理缺乏准确的风险分层。本研究将HPV整合状态作为诊断为CIN2的18至45岁女性的预后生物标志物进行研究，目的是开发一种预测工具，用于制定个性化治疗策略，并尽量减少对这一高消退率人群的过度治疗。
本多中心队列研究将在中国东部、西部、中部和北部地区的20家三级甲等医院开展。将招募240例CIN2患者，通过问卷收集社会人口统计学、生活方式和病史数据。在基线和随访时进行临床检查。评估疾病消退（至宫颈上皮内瘤变1级[CIN1]或更低）和未消退（持续性CIN2或进展）情况。将使用Cox比例风险模型分析预后因素，并对年龄、体重和社会经济地位等混杂因素进行调整。
队列研究方案和知情同意程序遵循《赫尔辛基宣言》和中国相关临床研究法规。已获得福建省妇幼保健院临床研究审查委员会（2022KYLLR01018）及各参与医院的伦理批准。在入组前，所有参与者均获得书面知情同意，并提供了有关研究目的、程序、潜在风险和益处以及参与者权利的详细信息。研究结果将发表在同行评审的科学期刊上，在学术会议上展示，并通过新闻稿向公众发布。
ClinicalTrials.gov（NCT05282095）；预结果。
