Active not recruitingOBSERVATIONAL

Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma

This research is looking for better ways to check if head and neck cancer might return after treatment. We're focusing on patients with advanced head and neck cancer, including those with HPV-positive and HPV-negative types. The study uses a special blood test to find tiny fragments of cancer DNA, called ctDNA, or HPV DNA, in real-time. We want to see how these DNA levels change after standard treatments like surgery, radiotherapy, or chemoradiotherapy. The main goal is to understand if detecting these DNA fragments can help predict if the cancer will come back, and to work out the best time to check for them in future studies. This could lead to more personalised and effective ways to monitor and treat head and neck cancer.

At a glance

Status

Active not recruiting

Sponsor

University Health Network, Toronto

Enrolment target

Start

15 Oct 2020

Estimated completion

30 Jun 2026

Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Cancer

What is this study about?

This research study is about finding new and better ways to track head and neck cancer, especially in people who have more advanced stages of the disease. We're looking at patients who are starting standard treatments for their cancer, such as surgery, radiation, or a combination of radiation and chemotherapy.

The main idea is to use a special blood test that can detect very small pieces of cancer DNA, or DNA from the HPV virus (which can cause some head and neck cancers). These tiny DNA fragments are called 'circulating tumour DNA' (ctDNA) or 'HPV DNA'. By taking blood samples from patients during and after their treatment, we hope to see how these DNA levels change. This could help us understand if the cancer is gone, if it's likely to come back, and when is the best time to check for it.

Ultimately, this study aims to explore if these blood tests can act as an early warning system, helping doctors understand if someone's cancer might return after treatment. This knowledge could help improve how we monitor patients and potentially lead to more tailored treatments in the future, giving doctors and patients more information about their health journey.

Key takeaways

This study uses blood tests to look for cancer DNA in advanced head and neck cancer.
It aims to find new ways to detect if cancer might return after treatment.
Participation involves regular blood samples taken during and after your standard treatment.
The findings could help improve future monitoring and treatment for head and neck cancer.
Your standard cancer treatment will not be changed by taking part in this study.

Who may be eligible?

This study is for adults aged 18 or older who have advanced head and neck cancer. This includes cancers of the mouth, throat, or voice box. Your cancer can be either HPV positive or HPV negative, but it needs to be what doctors call 'stage III' for HPV positive cancer, or 'stage III-IV' for HPV negative cancer. To join, you must also be about to start standard cancer treatment, which might be surgery followed by radiation/chemotherapy, or just radiation, or radiation combined with chemotherapy.

To see if you can join, doctors will need a sample of your tumour tissue. You can't be in this study if your cancer is in a very early stage (stage I or II) or if it has already spread to distant parts of the body (this is called metastatic cancer).

If you're unsure if you fit these descriptions, it's always best to chat with your doctor or the research team.

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 advanced head and neck cancer of the mouth, throat, or voice box?
Are you about to start standard treatment (surgery, radiotherapy, or chemoradiotherapy)?
Has your doctor confirmed your cancer is 'stage III' or 'stage III-IV'?
Has your cancer not spread to distant parts of your body?

Answer every question to see your result.

What does participation involve?

This study will involve having regular blood tests taken during and after your standard cancer treatment. The researchers will be looking for cancer DNA in these blood samples. You will be going through your usual treatment plan for head and neck cancer, and this study won't change that. The study will also involve providing a sample of your tumour tissue, which is usually collected during your diagnosis or surgery. The total duration of your participation will depend on how long the study needs to monitor your DNA levels after treatment, which may extend for several weeks or months. Any specific visits or follow-up beyond your standard care will be explained by the study team.

Potential risks and benefits

Taking part in this study may offer the potential benefit of helping researchers better understand head and neck cancer and how to monitor it. While it might not directly benefit you personally, the information gained could lead to better care for future patients. The main risk involved is the discomfort of regular blood test needles. All medical procedures carry some slight risks, which the study team will explain fully. Remember, you can choose to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is head and neck squamous cell carcinoma?

It's a common type of cancer that starts in the moist lining of the head and neck area, like the mouth, throat, and voice box.

What is HPV DNA?

HPV DNA is genetic material from the Human Papillomavirus, which can cause some head and neck cancers. We're looking for tiny bits of it in your blood.

What is ctDNA?

CtDNA stands for 'circulating tumour DNA'. It's tiny bits of DNA released into the blood by cancer cells. Finding it could help us track the cancer.

Will this study change my treatment?

No, this study will not change your standard cancer treatment plan. It's about collecting extra information through blood tests alongside your usual care.

What does 'high-risk locally advanced' mean?

It means the cancer is more serious and has grown into nearby tissues, but it hasn't spread to distant parts of the body yet.