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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
United Kingdom
Kingston Hospital Foundation Trust
RECRUITING
Kingston Upon Thames
Northwick Park Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Shreerang Bhide
Shreerang.Bhide@rmh.nhs.uk
02073528171
Backup
Sarah Burton
enhance@rmh.nhs.uk
02073528171
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 170
Sponsors
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov