Research protocol on the impact of assessing the dynamic trajectory and the prediction of prognosis of HPV infection based on the spouse cohort of patients with oropharyngeal squamous cell carcinoma (SCOPE)

Abstract Background: Oropharyngeal squamous cell carcinoma (OPSCC) is one of the leading cancer burdens worldwide. In China, rates of age-standardized OPSCC and mortality incidences have dramatically been increasing in recent years. Most OPSCC cases are found to be induced by human papillomavirus (HPV) through the oral-genital route during sexual activities. Dramatically increasing incidences of HPV-associated OPSCC in Chinese couples are believed to be caused by altered sexual behaviors. However, a pathophysiological understanding of the correlation between HPV infections in spouses of HPV-OPSCC patients and the impact of post-treatment HPV status on the prognosis of OPSCC is still lacking in China and requires further epidemiological evaluations and confirmatory analyses. We aim to decipher crucial etiological indicators of HPV-OPSCC by analyzing the characteristics of HPV infection in patients’ spouses through multiple cross-sectional surveys and laboratory findings for current and follow-up visits. Methods: The spouse cohort of patients with oropharyngeal squamous cell carcinoma(SCOPE) is an open-ended bidirectional retrospective and prospective cohorts that aim to investigate the characteristics of HPV infections in spouses and their possible association with the etiological factors of HPV-OPSCC pathology through the deep analysis of long-term follow-up and laboratory data. This study proposal will adopt of more than 400 OPSCC patient-spouse pairs at Beijing Union Medical College Hospital from 2013 to date. The primary outcome is set as overall survival (OS) and disease-specific survival (DSS), and the secondary outcome is to explore the impact of HPV infection on the reproductive health and the next generation. Discussion: We found a correlation between HPV infection and the risk of developing OPSCC in Chinese couples. Furthermore, we compared HPV infection rates between OPSCC and non-OPSCC populations. We hypothesize that oral-genital sexual activities may play a crucial role in the pathogenesis of HPV-associated OPSCC. The absence of complete epidemiological evidence and conflicting results warrants further in-depth investigations to unveil HPV-OPSCC disease-causing factors in Chinese populations.