Liquid Biopsy for Early Diagnosis of Squamous Cell Carcinoma of the Head and Neck Region ENHANCE Study

What this Trial Is About

Head and Neck squamous cell carcinoma HNSCC has a 5-year survival rate of about 50 across all stages, with early stage I and II patients having better outcomes. This research focuses on improving early diagnosis of HNSCC by using a novel ultra-sensitive next generation sequencing NGS assay to detect circulating tumor DNA ctDNA in the blood, which is shed by cancer cells. The study aims to assess the sensitivity and specificity of this blood test in identifying early-stage HNSCC, potentially speeding up diagnosis and treatment pathways. This observational study uses a simple blood test liquid biopsy to detect ctDNA, including HPV DNA and genetic alterations associated with head and neck cancer. The assay offers a rapid turnaround time of 1 to 2 weeks, which may help reduce delays in the cancer referral and treatment process, especially in secondary care hospitals. The test is being evaluated in patients referred for ultrasound-guided fine needle aspiration in neck lump clinics, with no experimental drug or device intervention involved. Participants will provide blood samples during their clinic visits to allow researchers to measure the assays accuracy in detecting ctDNA. The main outcome is the tests sensitivity for early HNSCC detection within one year, alongside its specificity at baseline. The study involves routine clinical assessments and sample collection, with no additional treatment given. The total participation time varies, focusing on sample analysis and follow-up to understand the assays potential in earlier cancer diagnosis and improved patient outcomes.

Liquid Biopsy for Early DiagNosis of Squamous Cell Carcinoma of the HeAd and NeCk rEgion