RecruitingNCT05645783

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

Liquid Biopsy for Early DiagNosis of Squamous Cell Carcinoma of the HeAd and NeCk rEgion (ENHANCE Study)


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

170 participants

Start Date

Feb 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The 5-year survival for Head and Neck squamous cell carcinoma (HNSCC) across all TNM stage groups is approximately 50%. Patients who are present with stage I \& II disease have significantly better survival. When a patient presents to their general practitioner (GP) with symptoms suggestive of HNSCC, they may be referred for urgent specialist input through the suspected cancer referral (SCR) pathway, which include dedicated neck lump clinics. HNSCC is known to shed fragments of DNA, called circulating tumor DNA (ctDNA) into the bloodstream. The investigators have developed novel ultra-sensitive (\>90% sensitivity) next generation sequencing (NGS) assay for circulating HPV DNA in patients with non-metastatic locally advanced head and neck cancer. The use of ultra-sensitive NGS assay for detection of ctDNA using a simple blood test (liquid biopsy) holds a great promise for cancer screening and early diagnosis and can lead to better survival results and less disease burden. With a quicker turnaround (1-2 weeks), the liquid biopsy can help expedite the patient journey through the cancer pathways reducing the incidence of cancer target breaches. In order to design studies to test this hypothesis the investigators require preliminary data quantifying sensitivity and specificity of the assay in this setting.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients referred for an Ultrasound guided fine needle aspiration (USFNA) in the neck lump clinic

Exclusion Criteria3

  • Patient found to have a lump in the thyroid gland at the time of USFNA
  • Unable to give informed consent for biological sample collection
  • Unable to safely participate in clinic sample collection

Locations(2)

Kingston Hospital Foundation Trust

Kingston upon Thames, United Kingdom

Northwick Park Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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

Visit

NCT05645783


Related Trials