RecruitingNCT05097625

Head and Neck Early Relapse Detection Study (HERD)

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


Sponsor

University College, London

Enrollment

200 participants

Start Date

Jul 12, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking people with locally advanced head and neck squamous cell carcinoma (HNSCC) — specifically HPV-negative cancer — who are undergoing radical treatment (surgery, radiation, or chemotherapy). The goal is to detect cancer relapse earlier using blood tests and advanced MRI imaging. **You may be eligible if...** - You have been diagnosed with locally advanced HPV-negative head and neck squamous cell carcinoma, classified as intermediate or high risk - You are planned for radical treatment (surgery with or without additional therapy, or radical chemoradiation) - You are 18 or older - Your blood counts (neutrophils, platelets, hemoglobin) are within acceptable ranges **You may NOT be eligible if...** - Your cancer is HPV-positive - You have another active cancer at the same time - Scans show the cancer has already spread to distant sites (metastatic) - You have known hepatitis B, C, or HIV - You have contraindications to MRI (such as a pacemaker or severe claustrophobia) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Guy's and St Thomas'

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05097625


Related Trials