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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a blood-based test (called liquid biopsy) can help identify squamous cell carcinoma of the head and neck earlier and more accurately. It collects blood samples from patients who come to a neck lump clinic for a needle biopsy of a suspicious lump. **You may be eligible if...** - You are being referred to a neck lump clinic for an ultrasound-guided fine needle aspiration (a needle biopsy) of a lump in your neck - You are able and willing to provide a blood sample **You may NOT be eligible if...** - The lump in your neck turns out to be in your thyroid gland at the time of your biopsy - You are unable to give informed consent - Participating in the clinic visit safely is not possible for you 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.

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Locations(2)

Kingston Hospital Foundation Trust

Kingston upon Thames, United Kingdom

Northwick Park Hospital

London, United Kingdom

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NCT05645783


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