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Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
Study Purpose
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
- - TORS performed on or before 31st December 2021.
For the exploratory analysis only:Exclusion Criteria:
- Moderate to advanced stage T3-T4 oropharyngeal SCC.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
: 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.
Interventions
Genetic: - Molecular Analysis
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Other: - Radiomic/ Morphological analysis
Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
The Royal Marsden Hospital NHS Foundation Trust
London, ,
Site Contact
Andrew Williamson
[email protected]
02000000000
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