Multimodality detection of early relapse in radically treated high-risk HPV-negative head and neck squamous cell carcinoma: study protocol for a prospective multicentre UK cohort study (HERD).
Authors
Affiliations (22)
Affiliations (22)
- University College London, London, UK.
- Department of Biomedical Engineering and Imaging Science, King's College London, London, UK.
- Comprehensive Cancer Centre, King's College London, London, UK.
- Barts Cancer Institute Centre for Cancer Cell and Molecular Biology, London, UK.
- Cancer Research UK Cambridge Research Institute, Cambridge, UK.
- Department of Plastic & Reconstructive Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
- King's College London, London, UK.
- Saddle Point Science, York, UK.
- School of Cancer and Pharmaceutical Sciences, King's College London Faculty of Life Sciences and Medicine, London, UK.
- Guy's and St Thomas' Hospitals NHS Trust, London, UK.
- Neuroradiology, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
- Department of Medical Physics and Biomedical Engineering, University College London, London, UK.
- University College London Hospitals NHS Foundation Trust, London, UK.
- Barts and The London NHS Trust, London, UK.
- CR UK & UCL Cancer Trials Centre, London, UK.
- The Swallows Head and Neck Cancer Charity, Blackpool, UK.
- Department of Medical Oncology, St Bartholomew's Hospital, London, UK.
- King's Health Partners Cancer Biobank, King's College London, London, UK.
- UCL, London, UK.
- Division of Surgery and Interventional Science, University College London, London, UK.
- UCL Cancer Institute, London, UK [email protected].
- Department of Cancer Services, University College London Hospitals NHS Foundation Trust, London, UK.
Abstract
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. Design: Prospective, observational cohort study. Secondary and tertiary NHS hospitals in the UK. 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. 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. Development and independent validation of a multimodal recurrence risk prediction model. 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. 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. NCT05097625.