Actively Recruiting

Age: 18Years +
All Genders
NCT05645783

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

Led by Royal Marsden NHS Foundation Trust · Updated on 2024-08-09

170

Participants Needed

2

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred for an Ultrasound guided fine needle aspiration (USFNA) in the neck lump clinic
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Kingston Hospital Foundation Trust

Kingston upon Thames, United Kingdom, KT27QB

Actively Recruiting

2

Northwick Park Hospital

London, United Kingdom, HA13UJ

Not Yet Recruiting

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Research Team

S

Shreerang Bhide

CONTACT

S

Sarah Burton

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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