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Updated: Sep 26, 2026
RNAscope for In situ Detection of Transcriptionally Active Human Papillomavirus in Head and Neck Squamous Cell Carcinoma
Published on: March 11, 2014
Multimodality detection of early relapse in radically treated high-risk HPV-negative head and neck squamous cell
Sanjena Mithra1,2, Ahmed Abdullah Ahmed3, Amit Roshan4,5,6
1University College London, London, UK.
Introduction:
Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer globally, with over 12 000 new cases annually in the UK. Despite aggressive radical treatment, approximately 50% of patients with locally advanced (stage III/IV), human papilloma virus (HPV)-negative disease relapse within 2 years, often in the first year. Although current post-treatment follow-up schedules are recommended by clinical guidelines, imaging surveillance is led by symptoms after the initial 3 months and reliable biomarkers for early relapse are lacking. Consequently, recurrences are frequently detected too late for surgical salvage, though timely surgery can improve survival by up to 73% in selected cases. Head and Neck Early Relapse Detection Study represents a large-scale, prospective effort to integrate imaging, genomic, immunologic and microbiome datasets for relapse risk stratification and post-treatment surveillance in this high-risk patient group.
Methods And Analysis:
Design: Prospective, observational cohort study.
Setting:
Secondary and tertiary NHS hospitals in the UK.
Participants:
Recruiting up to 200 patients with stage III/IV (high-risk) HPV-negative HNSCC. Participants are enrolled into discovery (n=100) and validation (n=100) cohorts. Patients with HPV-positive tumours, metastatic disease or other contraindications defined in the protocol will be excluded.
Interventions:
Observational study with no experimental intervention. Participants are followed for 2 years with longitudinal collection of blood, saliva, urine, stool, fresh and archival tumour tissue and advanced MRI where possible in addition to their standard of clinical care.
Primary Outcomes:
Development and independent validation of a multimodal recurrence risk prediction model.
Secondary Outcomes:
Identifying patient populations for primary treatment stratification, establishment of a longitudinal biorepository and identifying biological mechanisms of recurrence. Multimodal data will be integrated using machine learning and Bayesian modelling.
Ethics And Dissemination:
Ethical approval was granted by the Bromley Research Ethics Committee (21/PR/1581). Findings will be disseminated through peer-reviewed publications, conference presentations and scientific meetings.
Trial Registration Number:
NCT05097625.
