RecruitingOBSERVATIONAL

Immune Biomarker Study for Head and Neck Cancer

This research aims to understand how your body's natural defence system, called the immune system, interacts with head and neck cancer. Doctors want to find specific clues, known as 'biomarkers', both in the tumour itself and in your blood, when you are first diagnosed. By comparing these clues, they hope to create a better way to predict how the cancer might progress. They will also grow small models of tumours in the lab to study them further. Ultimately, this study could lead to new ways to group head and neck cancers based on these immune system clues, potentially helping doctors choose more effective treatments in the future.

At a glance

Status

Recruiting

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

1,100

Start

16 May 2022

Estimated completion

31 Mar 2027

Head and Neck Cancer Oral Cavity Cancer Oropharyngeal Cancer Hypopharyngeal Cancer Laryngeal Cancer

What is this study about?

This study is designed to help us understand more about head and neck cancer by looking closely at your immune system. Your immune system is your body's natural defence, fighting off infections and diseases. When you have cancer, your immune system tries to fight it, but sometimes the cancer finds ways to hide or resist these attacks. Researchers in this study want to find specific markers, called 'biomarkers', that show how your immune system is responding to the cancer.

They will look for these markers in your tumour tissue and in your blood when you are first diagnosed. By comparing what they find in the tumour and what's circulating in your blood, they hope to get a clearer picture of how your whole body is reacting to the cancer. This is important because understanding these immune responses better could help doctors predict how effective certain treatments might be or how the cancer might develop over time. They will also grow tiny versions of your tumour in the lab to study how they behave.

The main goal of this research is to develop a new scoring system based on these immune system clues. Currently, head and neck cancers are often grouped by their location (like in the mouth or throat), but this study hopes to group them based on their unique immune characteristics. This new way of looking at cancer could eventually help doctors offer more personalised and effective treatments for patients with head and neck cancer in the future.

Key takeaways

Understanding how your immune system fights head and neck cancer.
Looking for 'biomarkers' in your tumour and blood.
Aims to improve how doctors predict cancer behaviour.
Could lead to more personalised treatments in the future.
Participation involves providing samples, not receiving new treatments.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you would need to be newly diagnosed with a specific type of head and neck cancer called squamous cell carcinoma, located in areas like the mouth, throat, or voice box. Your cancer should not have spread to distant parts of your body, and you must be at least 18 years old. It’s also important that you understand what the study involves and are happy to give your consent.

There's also a 'control group' for people who don't have cancer but need surgery for other reasons related to their ear, nose, or face. For this group, you must not have had any previous or current cancer.

However, you wouldn't be able to join if your cancer has spread to other parts of your body. Also, if taking a tissue sample from your tumour would make it difficult for doctors to properly check your tumour later, you might not be suitable. Other reasons for not being able to take part include drug abuse, if you're unable to follow the study plan, or if there's a language barrier that prevents you from understanding the study properly.

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 newly diagnosed with head and neck squamous cell carcinoma?
Has your cancer not spread to distant parts of your body?
Are you at least 18 years old?
Do you understand what the study involves and are happy to give consent?
Do you not have any other current or past cancers (if joining the control group)?

Answer every question to see your result.

What does participation involve?

This study is 'non-interventional', which means you won't be given any new treatments or medicines as part of the research. Instead, the researchers will collect samples that are already being taken as part of your standard care, such as tissue from your tumour during surgery. They will also ask for additional samples of blood, saliva, and stool. These samples will be used to look for the immune system markers they are studying. There's no specific time limit for your participation mentioned, but it will involve providing these samples and allowing them to be stored for future research. You won't have extra hospital visits solely for this study, as the sample collection would happen alongside your planned medical procedures.

Potential risks and benefits

Taking part in this study won't directly improve your current treatment, as it's observational. However, by providing samples, you'll be contributing valuable information that could help doctors understand head and neck cancer better and lead to improved treatments for future patients. The main 'risk' involves the additional blood, saliva, and stool samples. Blood draws can sometimes cause minor bruising or discomfort. You always have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (3)

ENT - Head and Neck Surgery Department
Verified postcode
Erlangen, Germany· Recruiting
Maxillo-Facial-Surgery Department
Verified postcode
Erlangen, Germany· Recruiting
Radiation Oncology Department
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is an immune biomarker?

It's a clue or signal found in your body, like in your blood or a tumour, that tells doctors something about how your immune system is responding to the cancer.

Will this study change my cancer treatment?

No, this study is for research purposes only. It won't directly change the treatment you receive for your cancer.

What kind of samples will be collected?

Researchers will collect small samples of your blood, saliva, stool, and a piece of your tumour tissue, often during a procedure you're already having.

Who is funding this research?

The information provided doesn't specify the funding source. This is a good question to ask the study team.

Is the study just for head and neck cancer?

Yes, this specific study is focused on people who have been diagnosed with head and neck cancer, specifically squamous cell carcinoma.

How to find out more

Antoniu-Oreste Gostian, PD Dr. med.

antoniu-oreste.gostian@uk-erlangen.de +49 9131 85-33156 Official trial record

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