At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Molecular Analysis (genetic), Radiomic/ Morphological analysis (other)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- Molecular Analysis — genetic: Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples · 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 250
- Started
- 2023-12-19
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for cancer head neck
- • Clinical study - 250 participants
- • Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cancer head neck
Where?
- • London - The Royal Marsden Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ for international centres)
What the study is looking for
- ✓18 years and older.
- ✓Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior...
- ✓confirmed by a biopsy squamous cell carcinoma.
- ✓P16 positive or negative tumours
- ✓Index cancer treated with TORS with or without after surgery therapy.
Who cannot take part
- ✗Moderate to advanced stage T3-T4 oropharyngeal SCC
- ✗TORS performed for diagnostic, recurrent, or palliative intentions.
- ✗Prior history of head and neck cancer or radiotherapy at any time
- ✗Known distant that has spread disease.
- ✗Nasopharyngeal, thyroid, cutaneous, and non-SCC head and neck cancers.
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
How to Get in Touch
Andrew Williamson
Sponsor contactCONTACT
Reyhaneh Sadegh Zadeh
Sponsor contactCONTACT