A Prospective Cohort Study of Patients With Radically Treated Newly Diagnosed Locally Advanced HPV Negative Head and Neck Cancer to Develop and Validate a Multimodal Signature to Risk-stratify for Recurrence

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed, locally advanced HNSCC, HPV negative considered as intermediate or high risk .

• Offered radical treatment. (This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation).

• Age ≥ 18 years.

• Adequate bone marrow function (nNeutrophils, platelets and haemoglobin grade 0 or 1 according to CTCAE).

Locations
Other Locations
United Kingdom
Guy's and St Thomas'
RECRUITING
London
Contact Information
Primary
Trial Manager
NCITA.HERD@ucl.ac.uk
02076709274
Time Frame
Start Date: 2023-07-12
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 200
Treatments
High Risk Pathway
Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging
Low Risk Pathway
Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging
Sponsors
Collaborators: Cancer Research UK
Leads: University College, London

This content was sourced from clinicaltrials.gov