Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
The SCORE study is a international multicentre cohort study investigating the local recurrence free survival outcomes in patients undergoing transoral robotic surgery with and without adjuvant therapy for early stage (T1-T2) oropharyngeal squamous cell carcinoma (OPSCC). Important secondary objectives include assessment of other survival measures (overall, disease free and disease specific), determination of a safe margin "cut off" that minimises the risk of local recurrence, and reporting the rate of early post-operative complications and mortality. Retrospective SCORE patients will optionally contain an exploratory radiomic and radiology morphological analysis to ascertain high risk features of positive margins and local recurrence following TORS for early oropharyngeal cancer. Additionally, the SCORE study will contain a prospective exploratory molecular analysis of consenting patients to help further define OPSCC molecular characteristics in those who experience recurrence and those who do not, in addition to assessing levels of circulating tumour DNA in before and after TORS procedures.
Study Type
OBSERVATIONAL
Enrollment
250
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGTo report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
Time frame: 2 years
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Time frame: 2 years
To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Time frame: 2 years
To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Time frame: 2 years
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Time frame: 2 years
To report rates of 30-day post-operative mortality
To report rates of 30-day post-operative mortality
Time frame: 30 days
To report rates of 30-day post-operative haemorrhage
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To report rates of 30-day post-operative haemorrhage
Time frame: 30 days
To report rates of 30-day major haemorrhage necessitating surgical intervention
To report rates of 30-day major haemorrhage necessitating surgical intervention
Time frame: 30 days
To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy
To report the rate of feeding tube use at 12 months post-operatively
Time frame: 12 months
To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy
To report the rate of tracheostomy tube use at 12 months post-operatively
Time frame: 12 months
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
Time frame: 2 years