RecruitingOBSERVATIONAL

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

This study is exploring a new way to detect head and neck cancer early using a simple blood test, sometimes called a "liquid biopsy." Head and neck cancer can be tough to treat, especially if found late. At the moment, finding it early significantly improves treatment success. Researchers are developing a very sensitive blood test that can spot tiny fragments of cancer DNA, including HPV DNA, in the bloodstream. They believe this test could lead to quicker diagnoses (within 1-2 weeks), helping patients move through the healthcare system faster. This could mean more people start treatment earlier, potentially leading to better outcomes. This initial study aims to see how accurate and reliable this new blood test is.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

170

Start

01 Feb 2023

Estimated completion

01 Dec 2024

Head and Neck Squamous Cell Carcinoma

What is this study about?

Head and neck cancer is a type of cancer that can affect areas like your mouth, throat, or voice box. When it's found at an early stage, the chances of successful treatment are much higher. Unfortunately, many cases are diagnosed when the cancer is more advanced, making treatment more challenging. Currently, if you have symptoms that might suggest head and neck cancer, your GP would refer you to a specialist clinic for further checks, which can sometimes involve waiting for appointments and tests.

This study is investigating an exciting new tool called a "liquid biopsy." This isn't a traditional biopsy where tissue is removed; instead, it's a simple blood test. The idea is that cancer cells, even very early ones, release tiny pieces of their DNA into your bloodstream. Researchers have developed a very sensitive test to find these specific bits of DNA, including those related to the Human Papillomavirus (HPV), which can cause some head and neck cancers.

If this blood test proves to be accurate, it could transform how head and neck cancer is detected. Imagine being able to have a quick blood test that could help doctors identify cancer much earlier. This could significantly speed up the diagnosis process, meaning less waiting and quicker access to treatment. Getting treatment sooner often leads to better results for patients. This study is an important first step to see just how well this new blood test works in identifying head and neck cancer.

Key takeaways

This study evaluates a new blood test for early head and neck cancer detection.
The test looks for tiny bits of cancer DNA in the blood.
Early diagnosis can lead to better treatment outcomes.
Participation involves a single blood sample during a clinic visit.
The study aims to speed up the diagnosis process for future patients.

Who may be eligible?

This study is open to adults aged 18 and over, of any gender. To be considered, you must have been referred to a neck lump clinic for a special type of scan called an ultrasound-guided fine needle aspiration (USFNA).

However, some people won't be able to join. If during your USFNA, it's found that your lump is in your thyroid gland, you wouldn't be able to take part. Also, if you aren't able to understand and agree to participate in the study, or if it's not safe for you to provide the necessary samples, you won't be eligible.

Quick self-check

Are you 18 years old or older?
Have you been referred to a neck lump clinic for an ultrasound-guided fine needle aspiration (USFNA)?
Are you able to understand and agree to take part in the study?
Is your lump NOT found to be in your thyroid gland during the USFNA?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The study involves a simple blood test. If you are eligible and choose to take part, you would have a blood sample collected during your visit to the neck lump clinic for your planned ultrasound-guided fine needle aspiration (USFNA). No extra visits are needed just for the study, and there are no specific medications involved. The total duration of your direct involvement would be during that single clinic visit.

Potential risks and benefits

The main potential benefit of this study is contributing to important research that could lead to earlier and faster diagnosis of head and neck cancer for future patients, potentially improving their health outcomes. For participants, the risks are minimal, similar to those of a standard blood test, such as minor bruising or discomfort at the injection site. You are a volunteer, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Kingston Hospital Foundation Trust
Kingston upon Thames, United Kingdom· Recruiting
Northwick Park Hospital
London, United Kingdom· Not yet recruiting

Common questions

What is a 'liquid biopsy'?

It's a simple blood test that looks for tiny pieces of cancer DNA that might be shed into your bloodstream.

Why is early diagnosis so important for head and neck cancer?

Finding head and neck cancer early often means treatment is more effective, leading to better chances of recovery.

Will this blood test replace other diagnostic tests?

This study is an early step. If successful, it could help speed up diagnosis but would likely work alongside other important tests, not replace them right away.

Do I need to do anything special to prepare for the blood test?

No, there are no special preparations needed for the blood test itself beyond what you would normally do for your clinic visit.

Will taking part in this study affect my usual care?

No, your decision to take part or not, and your participation, will not affect your regular medical care or treatment.

How to find out more

Shreerang Bhide

Shreerang.Bhide@rmh.nhs.uk 02073528171 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.