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| ID | Type | Description | Link |
|---|---|---|---|
| CCR5852 | Other Identifier | Royal Marsden Committee for Clinical Research | |
| IRAS327707 | Other Identifier | UK NHS HRA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective observational cohort | 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. | ||
| Exploratory molecular analysis | 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. |
| |
| Radiology/ radiomic 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Analysis | Genetic | Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer. |
Inclusion Criteria:
For the exploratory analysis only:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Williamson | Contact | 02000000000 | andrew.williamson2@rmh.nhs.uk | |
| Reyhaneh Sadegh Zadeh | Contact | 02000000000 | reyhaneh.sadeghzadeh@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Vinidh Paleri | Royal Marsden Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden Hospital NHS Foundation Trust | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35944904 | Background | Hardman JC, Holsinger FC, Brady GC, Beharry A, Bonifer AT, D'Andrea G, Dabas SK, de Almeida JR, Duvvuri U, Floros P, Ghanem TA, Gorphe P, Gross ND, Hamilton D, Kurukulasuriya C, Larsen MHH, Lin DJ, Magnuson JS, Meulemans J, Miles BA, Moore EJ, Pantvaidya G, Roof S, Rubek N, Simon C, Subash A, Topf MC, Van Abel KM, Vander Poorten V, Walgama ES, Greenlay E, Potts L, Balaji A, Starmer HM, Stephen S, Roe J, Harrington K, Paleri V. Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study. J Natl Cancer Inst. 2022 Oct 6;114(10):1400-1409. doi: 10.1093/jnci/djac130. | |
| 35636080 |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000072662 | Margins of Excision |
| D009959 | Oropharyngeal Neoplasms |
| D009364 | Neoplasm Recurrence, Local |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Samples to be collected for germline and circulating tumour DNA analysis:
Samples to be taken as part of standard care for molecular analysis:
- Fresh or Archival Tumour tissue (biopsies and resections)
| Radiomic/ Morphological analysis | Other | 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 disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. |
| 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. | 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 | 2 years |
| To report rates of 30-day post-operative mortality | To report rates of 30-day post-operative mortality | 30 days |
| To report rates of 30-day post-operative haemorrhage | To report rates of 30-day post-operative haemorrhage | 30 days |
| To report rates of 30-day major haemorrhage necessitating surgical intervention | To report rates of 30-day major haemorrhage necessitating surgical intervention | 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 | 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 | 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 | 2 years |
Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer. |
| 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 | 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. | 2 years |
| Correlation of high-risk radiomic/ or morphological features and local recurrence | Correlation of high-risk radiomic/ or morphological features and local recurrence | 2 years |
| Background |
| Warner L, O'Hara JT, Lin DJ, Oozeer N, Fox H, Meikle D, Hamilton D, Iqbal MS, Robinson M, Paleri V. Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. Oral Oncol. 2022 Jul;130:105909. doi: 10.1016/j.oraloncology.2022.105909. Epub 2022 May 26. |
| 37951118 | Background | Williamson A, Moen CM, Slim MAM, Warner L, O'Leary B, Paleri V. Transoral robotic surgery without adjuvant therapy: A systematic review and meta-analysis of the association between surgical margins and local recurrence. Oral Oncol. 2023 Dec;147:106610. doi: 10.1016/j.oraloncology.2023.106610. Epub 2023 Nov 9. |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |