The SCORE study
Research type
Research Study
Full title
Single and Combined modality trans-Oral Robotic surgery in Early oropharyngeal cancer: exploring the impact of surgical margins on local disease recurrence
IRAS ID
327707
Contact name
Vinidh Paleri
Contact email
Sponsor organisation
Clinical Research Performance & Quality
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Oropharyngeal squamous cell carcinoma (OPSCC) encompasses tumours of the tonsil and tongue base, and is increasingly common due to the rise of human papilloma virus associated cancers. Historically these tumours were managed with extensive open operations, however, with the advent of minimally invasive transoral robotic procedures (TORS), many patients are now amenable less extensive treatment that avoids the long-term complications of open surgery and chemoradiotherapy. The success of TORS is highly dependent on achieving adequate surgical margins, however what constitutes a “safe” or “close” margin in OPSCC is poorly defined.
We will conduct a retrospective study of patients presenting with early primary OPSCC that are amenable to treatment with TORS alone. We aim to define the optimum margin cut off that minimises the risk of tumour relapse, in addition to determining the survival outcomes and short term complications associated with primary TORS. Additionally, we will use blood, saliva and tissue samples to perform DNA analysis to gain a deeper understanding of the genetic mechanisms that give rise to OPSCC. Finally, we will use machine learning radiomic analysis of CT and MRI scans to identify TORS patients that are an elevated risk of locoregional recurrence.
Information will be taken from clinical records and will not require any patient input. In patients who agree to the optional molecular and radiomic sub-studies, informed consent will be sought, and timing of blood/ saliva tests will coincide with their routine follow-up. The study will be conducted over one year, recruiting patients operated on at any point up to September 2022 to allow a sufficient period of clinical follow-up.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0198
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion