Active not recruitingOBSERVATIONAL

Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

This study aims to improve how doctors find the original source of a type of cancer called squamous cell carcinoma, which affects the throat area. Sometimes, this cancer is first found in the lymph glands in the neck, but the main starting point, called the 'primary,' isn't clear. This is known as a 'cancer of unknown primary' (CUP). The study focuses on two areas where these cancers often begin: the tonsils and the back of the tongue. While tonsils can be removed for examination, a newer operation, 'tongue base mucosectomy' (TBM), allows doctors to check the back of the tongue. This research will use an advanced lab method called 'step serial sectioning' to examine these tissues more closely, hoping to identify the primary cancer more effectively. Patients will also share their experiences with pain and swallowing after surgery.

At a glance

Status

Active not recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

100

Start

01 Nov 2019

Estimated completion

01 Dec 2030

Squamous Cell Carcinoma of the Oropharynx

What is this study about?

Imagine you have a small fire, and smoke appears in another room. Doctors see the smoke (cancer in the neck glands), but they can't immediately find the small fire (where the cancer started). This can sometimes happen with a type of cancer called squamous cell carcinoma, which often affects areas like the throat. When the starting point isn't clear, doctors call it a 'cancer of unknown primary' (CUP) of the head and neck.

This study is looking at a new and improved way to find that original 'fire.' Cancers in this area often start in two main places: the tonsils or the tissue at the back of your tongue (called the tongue base). While doctors can already remove tonsils to check them, there's a newer operation called 'tongue base mucosectomy' (TBM) specifically designed to check the tongue base.

The main goal of this research is to improve how accurately doctors can find where the cancer originally came from. Tissues removed from the tonsils and tongue base will undergo a very detailed lab process called 'step serial sectioning' (SSS). This is like taking many, very thin slices of the tissue to look at every tiny bit under a microscope, making it much more likely to spot any hidden cancer cells. By doing this, doctors hope to get a clearer picture of the cancer, which can help guide future treatment decisions. We also want to understand patients' experiences after these operations, including their pain and how well they recover with eating and drinking.

Key takeaways

This study aims to find the original source of throat cancer more effectively.
It uses a special, detailed lab test on tissue from the back of the tongue and tonsils.
Participation involves giving consent for tissue analysis and completing questionnaires.
There are no extra surgeries or medications involved in the study.
Finding the primary source can help doctors plan the best treatment for you.
Your personal information will be kept private and anonymous.

Who may be eligible?

To be considered for this study, you would need to be aged 16 or older, regardless of whether you are male or female. The main requirement is that you have a specific type of cancer called squamous cell carcinoma, which has been confirmed to be in the lymph glands of your neck, and your doctors are planning to use the 'tongue base mucosectomy' (TBM) operation to try and find where the cancer originally started.

However, you would not be able to join the study if doctors have already found the original site of your cancer before the TBM operation. You also wouldn't be eligible if you're having other types of specific biopsies or operations that aren't TBM, or if you've had head and neck cancers or radiation treatment to your head and neck area in the past.

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 16 years old or older?
Have you been diagnosed with squamous cell carcinoma in your neck lymph glands?
Are your doctors planning a 'tongue base mucosectomy' (TBM) operation for you to find the cancer's origin?
Has the original cancer site NOT been found yet?
Have you NOT had head and neck cancer or radiation treatment in that area before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your planned surgery (tongue base mucosectomy) as decided by your doctors. After your operation, the tissue removed from your tongue or tonsils will be examined using a special, very detailed lab method called 'step serial sectioning,' in addition to the usual checks. You'll be asked to let us use this tissue for research after it's been checked for your medical care. All your personal details will be kept private, and your tissue samples will be sent to a special lab in Newcastle for analysis without your name attached.

We will also gather some general information about your diagnosis and the care you receive. You'll be asked to fill out short questionnaires about your pain and how well you are swallowing after your surgery. A small number of patients will also have the option to be interviewed to share their thoughts and feelings about having a 'cancer of unknown primary' and the treatment they received. The study doesn't involve any extra doctor visits beyond your usual medical care, and your involvement will last for the period it takes to collect this information and your feedback.

Potential risks and benefits

Taking part in this study means your doctors might have a better chance of finding where your cancer started, which can help them plan the best treatment for you. There are no additional medical risks from being in the study itself, as the tissue used is already being removed as part of your surgery, and you are not receiving any extra treatments. The main commitment is completing questionnaires and potentially an interview. You are free to decide not to take part or to withdraw from the study at any time, for any reason, and this will not affect your medical care.

Locations (1)

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

University Hospitals Birmingham NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom

Common questions

What is 'squamous cell carcinoma'?

It's a common type of cancer that starts in the thin, flat cells that line parts of your body, like the surface of your skin, the mouth, and the throat.

What does 'cancer of unknown primary' mean?

It means cancer is found in places like your neck lymph glands, but after checks, doctors haven't yet found the exact spot where the cancer originally began.

What is a 'tongue base mucosectomy'?

It's an operation where doctors carefully remove a small section of tissue from the very back of your tongue to check if cancer cells are present there.

Will taking part mean I get different treatment?

No, your medical care and treatment will be based on what your doctors decide is best for you, regardless of whether you join the study. The study aims to gather more information from your existing care.

Will my personal details be shared?

No. All your samples and information will be anonymised, meaning your name or anything that could identify you will be removed before analysis.