RecruitingOBSERVATIONAL

Immune Biomarker Study for Salivary Gland Carcinoma

This study aims to understand the immune system in people with salivary gland cancer. Salivary gland cancers are rare and diverse, making them hard to study properly. This research will collect samples, like blood and tissue, from people with cancerous and non-cancerous salivary gland lumps, as well as those having other head and neck surgeries. By looking closely at these samples, researchers hope to find specific signals (biomarkers) that can help predict which treatments, especially new immune-boosting therapies, might work best. This could lead to more personalised and effective treatments for salivary gland cancer patients in the future.

At a glance

Status

Recruiting

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

300

Start

08 Jan 2024

Estimated completion

30 Sep 2031

Salivary Gland Tumor Benign Salivary Gland Tumor

What is this study about?

This study is about understanding a specific type of cancer called salivary gland carcinoma, which is quite rare. Salivary glands produce saliva in your mouth, and a carcinoma means a cancerous growth. Because these cancers are uncommon and can vary a lot from person to person, they haven't been studied as much as other cancers.

The main goal of this research is to look at how your body's immune system, which is your natural defence against illness, reacts to these cancers. Researchers believe that by understanding these immune responses, they can develop better ways to treat salivary gland cancer, especially by using treatments that boost your own immune system (called immunotherapy).

To do this, the study will collect different samples from patients. They will compare samples from people with salivary gland cancer to samples from people with non-cancerous (benign) salivary gland lumps, and even from people having nose or ear surgery. By comparing all these samples, they hope to find specific immune markers or signals that can help doctors decide the best treatment path for each patient.

Key takeaways

This study looks at your body's natural defence system (immune system) and salivary gland cancer.
It aims to find new ways to use immune-boosting treatments (immunotherapy).
Participation involves providing tissue, blood, saliva, and stool samples.
Patients receive their standard medical care; no new treatments are given in this study.
Your contribution could help improve future treatments for salivary gland cancer.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and be able to understand what the study is about and agree to take part. Researchers are looking for people with a new diagnosis of salivary gland cancer in their head or neck, or those with a newly diagnosed non-cancerous lump in their salivary gland. Also, some people having nose, ear, or jaw surgery who don't have a salivary gland issue might be included.

There are certain reasons why you might not be able to join. For example, if your cancer has already spread to other parts of your body, or if you've had another type of cancer within the last five years (unless it was a very specific, easily treated skin cancer or cervical condition). You also can't join if taking a tissue sample would harm your diagnosis, or if you have substance abuse issues or a language barrier that prevents you from understanding the study.

It's important that you are willing and able to follow the study's instructions and provide blood, saliva, and stool samples for research. The study also needs you to agree to have your samples stored for future research.

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?
Have you been newly diagnosed with a salivary gland lump (cancerous or non-cancerous), or are you having nose/ear/jaw surgery?
Are you able to understand the study and willing to give samples (blood, saliva, stool)?
Do you not have cancer spread to other parts of your body or another cancer diagnosis in the last 5 years (except certain minor skin/cervical cancers)?
Are you able to follow the study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing involved is providing different samples for the researchers to study. This would include a small piece of the tumour tissue collected during your surgery (if you're having one). Researchers will make sure taking this piece doesn't affect your regular diagnosis.

You will also be asked to provide blood, saliva, and stool samples. For people with cancer, blood samples will be taken before and after your surgery, and potentially after any additional treatments like chemotherapy or radiotherapy, if you have them. Researchers will also collect some information about your health background and how you respond to treatment. The total duration of your participation will depend on your specific treatment plan, but it's primarily an observational study, meaning you won't be given any new medications as part of the research itself.

Potential risks and benefits

The main potential benefit of taking part is contributing to new knowledge that could improve treatments for salivary gland cancer in the future. While you won't receive new treatments as part of this study, your information and samples could help doctors understand the disease better and guide future research. The main risks are minor, such as discomfort from blood draws. There is a small theoretical risk that the tissue sample might slightly affect the pathologist’s ability to assess your tumour, but the researchers will try to avoid this. You always have the right to withdraw from the study at any time without explaining why, and this will not affect your medical care.

Locations (2)

Universitätsklinikum Erlangen, HNO
Verified postcode
Erlangen, Germany· Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is a salivary gland carcinoma?

It's a rare type of cancer that starts in the glands in your mouth that produce saliva.

What is immunotherapy?

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

Will I get a new treatment in this study?

No, this is an observational study. You won't receive extra treatments as part of the research. Your usual medical care will continue as planned.

What kind of samples will be collected?

Researchers will collect small tissue samples, as well as blood, saliva, and stool samples.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Studiensekretariat

studiensekretariat.st@uk-erlangen.de +49913185 Official trial record

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