TY - JOUR
T1 - Assessing the burden of HPV-related head and neck cancers in mainland China
T2 - Protocol of a nationwide, multisite, cross-sectional study
AU - Wang, Wei
AU - Song, Cheng
AU - Su, Zheng
AU - Kothari, Smita
AU - Chen, Ya Ting
AU - Liu, Yin
AU - Wu, Shu Yu
AU - Panchal, Ravi
AU - Morais, Edith
AU - Zhang, Shao Kai
AU - Yin, Jian
AU - Qiao, You Lin
AU - Roberts, Craig
N1 - Publisher Copyright:
© 2023 Author(s). Published by BMJ.
PY - 2023/11/15
Y1 - 2023/11/15
N2 - Background Persistent human papillomavirus (HPV) infection is a known cause of a subset of head and neck cancers (HNCs). In the last two decades, the proportion of HNCs attributable to HPV infection has increased worldwide, notably the oropharyngeal cancers. However, the trend of HPV-related HNC burden is not clearly understood yet in China. Thus, the absolute burden of HPV-related head and neck cancers in China (BROADEN-China) will be conducted to estimate the proportion of HNCs attributable to HPV infection, per anatomic site, by genotype, in three time periods (2008-2009, 2013-2014 and 2018-2019). Methods and analysis BROADEN-China is a nationwide, multisite, cross-sectional study. A stratified, multistage, non-randomised cluster sampling method will be used to select 2601 patients with HNC from 14 hospitals across seven regions, based on population density in China. Patients with formalin-fixed paraffin-embedded tissue samples collected prior to treatment induction during three time periods will be included, and factors (eg, smoking status, alcohol consumption, betel nut chewing, Epstein-Barr virus, teeth loss, etc) associated with HNC will be assessed. HPV testing (HPV-DNA, HPV-mRNA and p16 INK4a immunohistochemistry) and histological diagnosis of the tissue samples will be conducted at a central laboratory. The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. The informed consent was waived for all participants and all the recorded data will be treated as confidential. We have included 14 hospitals as our participating sites, of which Henan Cancer Hospital is the leading site. The study has been approved by the independent ethics committees of the leading site on 3 December 2020. The other 13 participating site names of ethics committee and IRB that have approved this study.
AB - Background Persistent human papillomavirus (HPV) infection is a known cause of a subset of head and neck cancers (HNCs). In the last two decades, the proportion of HNCs attributable to HPV infection has increased worldwide, notably the oropharyngeal cancers. However, the trend of HPV-related HNC burden is not clearly understood yet in China. Thus, the absolute burden of HPV-related head and neck cancers in China (BROADEN-China) will be conducted to estimate the proportion of HNCs attributable to HPV infection, per anatomic site, by genotype, in three time periods (2008-2009, 2013-2014 and 2018-2019). Methods and analysis BROADEN-China is a nationwide, multisite, cross-sectional study. A stratified, multistage, non-randomised cluster sampling method will be used to select 2601 patients with HNC from 14 hospitals across seven regions, based on population density in China. Patients with formalin-fixed paraffin-embedded tissue samples collected prior to treatment induction during three time periods will be included, and factors (eg, smoking status, alcohol consumption, betel nut chewing, Epstein-Barr virus, teeth loss, etc) associated with HNC will be assessed. HPV testing (HPV-DNA, HPV-mRNA and p16 INK4a immunohistochemistry) and histological diagnosis of the tissue samples will be conducted at a central laboratory. The study protocol and all required documents have been submitted for review and approval to the Independent Ethics Committees of all the participating sites. The informed consent was waived for all participants and all the recorded data will be treated as confidential. We have included 14 hospitals as our participating sites, of which Henan Cancer Hospital is the leading site. The study has been approved by the independent ethics committees of the leading site on 3 December 2020. The other 13 participating site names of ethics committee and IRB that have approved this study.
KW - EPIDEMIOLOGY
KW - INFECTIOUS DISEASES
KW - PREVENTIVE MEDICINE
KW - PUBLIC HEALTH
UR - https://www.scopus.com/pages/publications/85178244546
U2 - 10.1136/bmjopen-2023-073277
DO - 10.1136/bmjopen-2023-073277
M3 - Article
C2 - 37968007
AN - SCOPUS:85178244546
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e073277
ER -
