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RecruitingOBSERVATIONAL

Exploratory Study of Clonal Evolution in Cancer for Patients Undergoing Transoral Robotic Surgery for Radiation Exposed Residual/reCurrent Tumours of the Upper Aerodigestive Tract

This study aims to understand why head and neck cancers sometimes come back or new cancers appear in areas previously treated with radiotherapy. Radiotherapy is a strong treatment, but sometimes not all cancer cells are destroyed, or new ones develop later. By looking closely at the cancer's DNA, both from the original tumour and any new ones, researchers want to see how the cancer changes over time. This information could help doctors provide more effective and personalised treatments for patients whose cancer has returned or developed after radiotherapy, including treatments like a type of surgery called transoral robotic surgery.

At a glance

Status
Recruiting
Sponsor
Royal Marsden NHS Foundation Trust
Enrolment target
20
Start
18 Nov 2020
Estimated completion
07 Oct 2026

What is this study about?

This research is looking into head and neck cancers, specifically those that have been treated with radiotherapy before. Radiotherapy is a powerful treatment designed to cure cancer, but sometimes, even after this treatment, some cancer cells can remain, or new cancers can develop in the same area. For various reasons, these cancers might come back or appear differently than the original one.

The main goal of this study is to understand these changes. Researchers want to find out if the cancer that comes back is simply the original cancer that resisted the treatment, or if it's a new version of the cancer that has evolved and become different over time. They will do this by carefully examining the cancer's genetic material, its DNA.

Why is this important? If doctors can understand how these cancers change, they might be able to predict which treatments would work best for different patients. This could lead to more effective treatment plans, including deciding if surgery like transoral robotic surgery (TORS) is the best option, or if other medical treatments should be tailored to fight these changed cancer cells more effectively. Ultimately, the aim is to improve the care and outcomes for patients with head and neck cancer.

Key takeaways

  • The study aims to understand how head and neck cancers react to and change after radiotherapy.
  • It uses samples from your cancer and blood to check for genetic changes.
  • The research won't change your current treatment plan, but could help future patients.
  • Participation involves giving blood and saliva samples, and allowing tissue analysis.
  • You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

You might be able to join this study if you are over 18 years old and have had head and neck cancer that was treated with radiotherapy in the past. You should also be planning to have a specific type of surgery called Transoral Robotic Surgery (TORS) for remaining cancer, cancer that has come back, or a new cancer in the head and neck area.

However, you would not be able to join if your TORS surgery is only being done to get a diagnosis, rather than to remove the cancer. Also, people with certain types of head and neck cancer, like those affecting the nose and throat (nasopharyngeal) or thyroid gland, are not included in this study.

For some parts of the study, if there aren't any tissue samples available from your original cancer or any new tumours, you wouldn't be able to participate.

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.

  1. Are you over 18 years old?
  2. Have you previously had head and neck cancer treated with radiotherapy?
  3. Are you having Transoral Robotic Surgery (TORS) for remaining, returning, or new head and neck cancer?
  4. Is your TORS surgery intended to remove cancer, not just for diagnosis?
  5. Are your head and neck cancer types not nasopharyngeal or thyroid cancer?
Answer every question to see your result.

What does participation involve?

If you join this study, it won't involve any extra appointments or changes to your planned medical care. Researchers will collect blood and saliva samples at specific times, usually before your surgery and then again after your surgery. They will also use tissue samples from your original cancer and the cancer removed during your surgery. These samples will be carefully analysed to understand how your cancer might have changed. The study primarily involves collecting and analysing these samples, so there are no new medications to take or additional clinic visits beyond your usual care.

Potential risks and benefits

Participating in this study will not involve any direct medical benefits for you, but the information gained is vital for helping future patients with similar conditions by improving our understanding of head and neck cancer. There are no significant risks associated with taking part; the blood and saliva collection are routine and tissue samples are taken as part of your planned surgery. You are free to withdraw from the study at any time without affecting your medical care.

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 'Transoral Robotic Surgery'?

It's a type of surgery where doctors use special robotic tools to remove tumours through the mouth, avoiding large incisions on the outside.

What does 'DNA analysis' mean?

It means scientists will look very closely at the genetic material of your cancer cells to understand their unique features and how they might have changed.

Will this study change my cancer treatment?

No, this is a research study to gather information. It won't change your planned cancer treatment, but the findings could help patients in the future.

How long will I be part of the study?

Your involvement in the study mostly revolves around the collection of samples at key points around your surgery. There are no long-term follow-up visits specifically for the study.

Where is this study taking place?

This study is being conducted at the Royal Marsden Hospital in Chelsea, London, which specialises in head and neck cancer care.

How to find out more

Vishak C Muraleedharan Shylaja, MBChB

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

Interested in taking part?

Register your interest

Share your details and the research team for "Exploratory Study of Clonal Evolution in Cancer for Patients…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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