An observational study in Cancer Head Neck, sponsored by Royal Marsden NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
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.
373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.
This study's planned enrollment of 250 is above the median of 111 across 66 observational studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 years and older diagnosed with early (T1-T2) primary oropharyngeal squamous cell carcinoma, treated with transoral robotic surgery with or without adjuvant therapy.
For the exploratory analysis only:
Exclusion Criteria:
Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 31/12/2021. Data will be collected from medical records.
Consenting prospective patients based in the UK identified will be invited to participate in the exploratory molecular analysis by their usual care team. If agreeable, patients will consent to donation of either blood or buccal swab samples, in addition to archival tissue from their primary, and if relevant, recurrent tissue samples.
Genetic: Molecular Analysis
Retrospective patients based in the UK and abroad will have their pre-operative imaging transferred to the RMH radiology department which will undergo radiomic and morphological assessment to ascertain features that put patients at high risk of local recurrence and positive margins.
Other: Radiomic/ Morphological analysis
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.
To 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
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
Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.
Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.
Time frame: 2 years
Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.
Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.
Time frame: 2 years
Correlation of high-risk genetic features with 2 year local recurrence outcomes
Correlation of high-risk genetic features with 2 year local recurrence outcomes
Time frame: 2 years
Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.
Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.
Time frame: 2 years
Correlation of high-risk radiomic/ or morphological features and local recurrence
Correlation of high-risk radiomic/ or morphological features and local recurrence
Time frame: 2 years
Plan to share: Undecided
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Royal Marsden NHS Foundation Trust