Just a moment, the page is loading...

Natural history of human papillomavirus and associated lesions in healthy Chinese women

Natural history of human papillomavirus and associated lesions in healthy Chinese women

Fanghui Zhao

National Cancer Center & Cancer Hospital,Chinese Academy of Medical Sciences

05 June 2020

Human papillomavirus(HPV) infection is a common viral infection that is often transmitted sexually. There are more than 100 different types of HPV. Many types do not cause any problems in most people, but some types are linked to cancer, especially cervical cancer. Nearly all cervical cancers (99.7%) are caused by infection with oncogenic HPV types, with HPV-16 and HPV-18 causing most (over 70%) cervical cancers.The number of cervical cancer cases diagnosed in China annually is higher than any other country, accounting for 20% of new cases worldwide. Understanding on natural history of HPV infection and associated progression and regression with cervical lesions is important to inform strategy of cervical cancer prevention and management in China. However, evidence about this is currently limited in China. An efficacy trial for AS04-HPV-16/18 vaccine was sponsored by GSK in health Chinese women aged 18-25 years old and registered on https://clinicaltrials.gov under number NCT00779766(HPV-039 trial). This provides a chance to look at the long-term development of cervical HPV infections and lesions with frequent follow-ups, which would not be feasible in ordinary screening-based studies. With this data, we propose to characterize type specific HPV cumulative incidence rate, progression rate and duration to cervical intraepithelial neoplasia(CIN) lesions, regression rate to lower grade lesions or normality and try to figure out whether there would be different histories between single and multiple infection. We also wish to add evidence to risk of newly detected infections and cervical abnormalities in women seropositive for naturally acquired HPV-16 or HPV-18 antibodies. Data on prognosis after cervical excisional treatment will also be analyzed. The findings would help to accumulate more data on accurate parameters about natural history of HPV infection and CIN development in Chinese women, which will be important for projection models on cervical cancer prevention in China.

[{ "PostingID": 2794, "Title": "GSK-107638", "Description": "Efficacy, immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV GSK 580299 vaccine in healthy Chinese female subjects" }]

Statistical Analysis Plan