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RecruitingOBSERVATIONAL

Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)

The VALUE study is investigating how a test called endoscopic ultrasound (EUS) helps doctors decide on the best treatment for people with oesophageal cancer. Each year, thousands of people in the UK are diagnosed with this cancer, and finding the right treatment early is really important. EUS involves a thin, flexible tube with a tiny camera and ultrasound probe to look closely at the oesophagus and nearby areas. Doctors use this information to understand how far the cancer has spread, which helps them plan surgery, chemotherapy, or other treatments. This study aims to understand how often EUS changes these treatment plans and what patients and doctors think about its usefulness, especially for those hoping for a cure.

At a glance

Status
Recruiting
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
160
Start
27 Jun 2024
Estimated completion
31 Dec 2026

What is this study about?

Each year in the UK, many people are diagnosed with oesophageal cancer. This disease can be very serious, and finding the best treatment as early as possible is crucial. Doctors often use several tests to understand the cancer, including CT and PET-CT scans. Another important test is called Endoscopic Ultrasound (EUS).

EUS is a special procedure where a doctor gently guides a thin, flexible tube down your throat. This tube has a camera and a small ultrasound device at its tip. This allows them to get a very close look at the oesophagus and nearby organs. It helps them see how deep the cancer has grown and if it has spread to nearby lymph nodes. This detailed information is vital for planning the most effective treatment, whether it's surgery, chemotherapy, or a combination.

The VALUE study is looking specifically at how this EUS test influences treatment decisions for people with oesophageal cancer, particularly those who have a chance of being cured. Researchers want to understand how often the EUS results lead to a change in the treatment plan after other scans have been done. They also want to gather opinions from both patients and doctors about how useful EUS is in deciding on the best course of action. This will help improve care for future patients.

Key takeaways

  • This study is about oesophageal cancer.
  • It looks at a test called Endoscopic Ultrasound (EUS).
  • It wants to know how often EUS changes treatment plans.
  • It also collects opinions from doctors and patients.
  • You won't have extra tests; your care stays the same.
  • The goal is to improve care for future patients.

Who may be eligible?

This study is looking for adults aged 16 or older who have recently been diagnosed with oesophageal cancer that has been confirmed by a biopsy. You would be considered if your doctors believe your cancer could potentially be cured with treatment like surgery or chemotherapy, and if you are already scheduled for an EUS test as part of your usual care.

To be included, your cancer would need to be located in the oesophagus or where it joins the stomach, and you would have already had CT and PET-CT scans. The study is particularly interested in common types of oesophageal cancer (adenocarcinoma or squamous cell carcinoma), and you should generally feel well enough to go about your daily activities with only slight limitations. You would not be able to join if your cancer has returned, spread to distant parts of your body, or if you've had previous surgery or radiation therapy for oesophageal cancer. Also, if you have other ongoing cancers or doctors think you can't have the EUS test for any reason, you wouldn't be able to take part.

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 16 years old or older with a new diagnosis of oesophageal cancer?
  2. Are your doctors planning an EUS test for you as part of your usual care?
  3. Do your doctors believe your cancer could potentially be cured with treatment?
  4. Have you already had CT and PET-CT scans?
  5. Is your cancer one of the common types (adenocarcinoma or squamous cell carcinoma)?
  6. Do you generally feel well enough to do most daily activities?
Answer every question to see your result.

What does participation involve?

If you take part in the VALUE study, you won't have any extra appointments or tests beyond what your doctors would normally recommend for your cancer care. This is an 'observational' study, which means the researchers will simply gather information and records from your standard medical care, including the results of your EUS test and other scans. They will also look at how your treatment plan is decided. Some participants, and the doctors involved in their care, might be asked to share their thoughts and opinions about the EUS test through a discussion or interview. The total duration of your participation will depend on your treatment pathway and follow-up, but it mainly involves allowing researchers to access your medical information.

Potential risks and benefits

There are no direct risks or benefits to you from participating in this study, as it only involves collecting information from your routine medical care and possibly sharing your opinions. You won't be given any new treatments or tests. Your medical care will remain exactly the same as if you weren't in the study. The potential benefit is that the information gathered will help doctors understand and improve the use of the EUS test for future patients with oesophageal cancer. You are always free to change your mind and withdraw from the study at any time, without it affecting your medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cwm Taf UHB
    Verified postcode
    Abercynon, United Kingdom· Recruiting
  • Royal Bournemouth Hospital
    Verified postcode
    Bournemouth, United Kingdom· Terminated
  • Cambridge University NHS Foundation Trust
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Cardiff and Vale UHB
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Velindre University NHS Trust
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Glasgow Royal Infirmary
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • Castle Hill Hospital
    Verified postcode
    Hull, United Kingdom· Recruiting
  • Guy's and St Thomas' NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Imperial College Healthcare NHS Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Queen's Medical Centre, Nottingham
    Verified postcode
    Nottingham, United Kingdom· Recruiting
  • Salford Royal Hospital
    Verified postcode
    Salford, United Kingdom· Recruiting
  • University Hospital Southampton
    Verified postcode
    Southampton, United Kingdom· Recruiting

Common questions

What is EUS?

EUS stands for Endoscopic Ultrasound. It's a procedure where a thin, flexible tube with a camera and an ultrasound device is guided into your oesophagus to get detailed pictures of the cancer and nearby areas.

Why is this study being done?

The study aims to understand how often the EUS test helps doctors make treatment decisions for oesophageal cancer and what patients and doctors think about its usefulness.

Do I need to do anything extra if I join?

No, you won't have any extra tests or appointments. The study simply collects information from your standard medical care, and you might be asked for your opinions.

Will joining the study affect my treatment?

No, joining the study will not change your medical care or treatment plan in any way. You will receive the same care as if you were not in the study.

Who is funding this research?

The study information provided does not specify the funding source for this research.

How to find out more

Ben Lindfield

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 "Understanding the Variation of Modern Endoscopic Ultrasound …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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