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
- Not specified by the sponsor
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- 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
- 200
- Started
- 2023-07-12
- Last checked
- 2023-10
Plain English Summary
What is this study?
- • Testing a new treatment for head and neck cancer
- • Clinical study - 200 participants
- • Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with head and neck cancer
Where?
- • London - Guy's and St Thomas'
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone. More than 60% of cases are diagnosed at the locally advanced stage. These patients are treated with radical intent, using a combination of surgery, radiotherapy and/or chemotherapy. Unfortunately 5 in 10 patients relapse within 2 years, with most relapses occurring within the first year since treatment. Unlike many other solid tumours, 80% of relapses occur locoregionally. Salvage surgery offers the best chance of long-term survival for patients with loco-regional recurrence, but this is only possible if the recurrence is amenable to resection. Salvage surgery has been estimated to improve survival outcomes in relapsed cancer by up to 73%. For salvage surgery to be feasible, relapses need to be detected early. Current surveillance strategies have little evidence base, with imaging often driven by clinical symptoms - often when the recurrence is no longer amenable to salvage surgery. With this study, we will address the unmet clinical need to develop a risk-stratified surveillance pathway to enhance detection of early relapse of radically treated head and neck cancer. At present, tumour grade and biomarkers such as HPV status have offered important but insufficient information to guide surveillance strategies.
More detail
AIMS: We hypothesise that risk of relapse relies on a dynamic interplay between the immune profile, tumour microenvironment, genetic signature and clinicopathological characteristics of the participant receiving treatment. Based on the recruitment of 200 participants within the study, we aim to generate sufficient evidence to guide a multi-analyte-based stratified imaging surveillance/follow up strategy to detect early relapse of cancer and improve survival. We will also develop a biorepository of data across a range of modalities to guide individualised treatment by precision medicine. OBJECTIVES: The primary objective is to develop and validate a multimodal signature to risk-stratify participants with radically treated head and neck cancer into different surveillance pathways. Non-invasive methods of surveillance, such as blood and saliva tests, will be used to monitor for relapse, with any abnormalities triggering imaging. This will facilitate early detection of relapse and facilitate salvage surgery, leading to better survival outcomes. DESIGN: This is a prospective cohort study of participants with newly diagnosed locally advanced HPV negative head and neck cancer, deemed to be intermediate or high risk (Figure 2A), referred to secondary care for radical treatment.
How this trial compares with your answers
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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
What the study is looking for
- ✓confirmed by a biopsy, that has grown locally HNSCC, HPV negative considered as intermediate or high risk .
- ✓Offered radical treatment. (This includes surgery and any postoperative after surgery/consolidation treatment, or radical...
- ✓Age ≥ 18 years.
- ✓Adequate bone marrow function (nNeutrophils, platelets and haemoglobin grade 0 or 1 according to CTCAE).
Who cannot take part
- ✗HPV positive disease.
- ✗Participants with concurrent cancer.
- ✗Confirmed distant that has spread disease on most recent imaging scan.
- ✗Known Hepatitis B, C or HIV infection .
- ✗Contraindications to MRI (including but not limited to heart pacemaker, metallic implants, major claustrophobia).
See the full criteria
Where Is This Study? (1 UK site)
Guy's and St Thomas'
London, United Kingdom
How to Get in Touch
Trial Manager
Sponsor contactCONTACT