RecruitingOBSERVATIONAL

Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck

This study focuses on head and neck cancer that has come back, spread, or can't be treated by surgery or radiation, meaning it can't be cured. For many people in this situation, unfortunately, life expectancy is short. While new treatments like immunotherapy can help some people live much longer, it's not clear why they work for some and not others. Researchers are collecting blood, saliva, and cancer tissue samples from patients undergoing treatment. They want to see if changes in these samples can give an early warning sign as to whether the treatment is effective. They will also try to grow cancer cells in the lab to test how they react to different treatments.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

09 Mar 2022

Estimated completion

01 Apr 2026

Head and Neck Cancer

What is this study about?

When head and neck cancer comes back, spreads, or can't be removed with surgery or treated with radiation, it can't be cured. Sadly, for many people in this situation, life expectancy can be short. However, new treatments, such as 'immunotherapy', have significantly helped some people live much longer. Immunotherapy works by boosting your body's own immune system to fight the cancer. The problem is that these treatments don't work for everyone, and at the moment, doctors don't know why or who will benefit.

This study, called DART, is trying to find ways to tell early on if a treatment is working. Researchers are collecting samples like blood and saliva, as well as small pieces of the cancer tissue, from people undergoing treatment. They want to look for tiny changes in these samples that could act as early signals to show if the cancer is responding to treatment. They will also try to grow the cancer cells in the lab to learn more about how they behave and how different treatments affect them.

The main goal is to understand why some people respond well to treatment and others don't. By finding these early signals, doctors hope to be able to choose the best treatment for each person much sooner. This could help ensure that patients receive the most effective care for their specific cancer.

Key takeaways

This study focuses on knowing if head and neck cancer treatment is working early on.
It uses blood, saliva, and cancer tissue samples for research.
The goal is to improve future treatments by understanding how immunotherapy works.
Participation involves giving extra samples during routine care, not extra visits.
You must have head and neck cancer that can't be cured and be on immunotherapy.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you would need to be 18 years old or older. You must have head and neck cancer that has either come back, has spread, or cannot be treated with the aim of curing it. You also need to be receiving treatment with immunotherapy.

It's important that you are able to give your clear permission (known as 'informed consent') to let the researchers collect your biological samples, such as blood, saliva, and tissue during your treatment.

If you are unable to provide samples regularly, or if you are pregnant, unfortunately, you would not be able to take part in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have head and neck cancer that has returned, spread, or cannot be cured by other methods?
Are you currently receiving immunotherapy treatment?
Can you provide your clear permission to give blood, saliva, and tissue samples for research?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you agree to take part in this study, the researchers will ask your permission to collect extra blood and saliva samples at the same time as your regular blood tests for treatment. They will also collect a small piece of your cancer tissue. Many people in this situation will have a small tissue sample taken with a needle anyway, and the research sample can often be taken at the same time.

For a small number of people, the researchers might also ask if you would be willing to have one extra tissue sample taken with a needle. This is to allow them to do more comparisons in the lab.

Taking part in this study will involve these extra sample collections alongside your regular cancer treatment. There are no additional medications or extra visits required specifically for the study, beyond what you would have for your standard care.

Potential risks and benefits

The main benefit of taking part is helping doctors learn more about head and neck cancer and how treatments work. This could lead to better treatments for future patients. There are no direct personal benefits expected from taking part. The main risks involve the collection of samples; for example, giving blood can cause slight bruising or discomfort, and a biopsy can have similar minor risks, although these samples are often taken as part of your routine care. You are free to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Royal Marsden Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system find and fight cancer cells.

Will taking part affect my cancer treatment?

No, taking part in this study will not affect the cancer treatment you receive. Your doctors will continue to give you the best care for your condition.

Will I get my results from the study?

The study aims to understand general patterns in cancer, so individual results may not be shared, as they are for research and not for guiding your personal treatment choices.

What exactly are 'early biomarkers'?

These are simply signs or signals, often found in blood or saliva, that can show very early on if a cancer treatment is having an effect.

Can I still join if I'm receiving different cancer treatment?

No, this study specifically needs patients who are receiving immunotherapy for head and neck cancer.

How to find out more

Ben O'Leary

ben.oleary@icr.ac.uk 02071535337 Official trial record

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