Liquid biopsy for early diagnosis of head and neck cancer
Liquid Biopsy for Early DiagNosis of Squamous Cell Carcinoma of the HeAd and NeCk rEgion (ENHANCE Study)
This study is testing a new blood test to see if it can help find head and neck cancer earlier in patients with neck lumps.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 2 sites (Kingston upon Thames and 1 other locations) |
| Trial ID | NCT05645783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the early diagnosis of head and neck squamous cell carcinoma (HNSCC) using a novel ultra-sensitive next generation sequencing (NGS) assay to detect circulating tumor DNA (ctDNA) in blood samples. Patients referred for ultrasound-guided fine needle aspiration (USFNA) in neck lump clinics will be included in the study. The goal is to identify HNSCC at earlier stages, which is crucial for improving survival rates, as early-stage patients have significantly better outcomes. By utilizing a simple blood test, the study seeks to streamline the diagnostic process and reduce delays in treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients referred for ultrasound-guided fine needle aspiration due to suspected head and neck lumps.
Not a fit: Patients with thyroid gland lumps or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of head and neck cancer, improving survival rates and reducing the burden of disease.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred for an Ultrasound guided fine needle aspiration (USFNA) in the neck lump clinic Exclusion Criteria: * 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
Where this trial is running
Kingston upon Thames and 1 other locations
- Kingston Hospital Foundation Trust — Kingston upon Thames, United Kingdom (Recruiting)
- Northwick Park Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Shreerang Bhide
- Email: Shreerang.Bhide@rmh.nhs.uk
- Phone: 02073528171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.