NCT05933889

Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer

Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence: The SCORE Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).

Detailed description

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.

Conditions

• Cancer Head Neck

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-19
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2023-07-06
• Last updated: 2024-08-07

Locations

1 site across 1 country: United Kingdom