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Nodule IMmunophenotyping Biomarker for Lung Cancer Early Diagnosis Study

The NIMBLE study aims to improve how doctors tell the difference between harmless lung growths, called nodules, and lung cancer. Many people have these nodules found on CT scans, which can cause worry. The study is using clever computer programs (artificial intelligence and machine learning) to analyse information from blood tests and CT scans. This could help doctors work out if a nodule is cancer, or if it's a new lung cancer or a spread from a previous cancer, much faster and more accurately. This could lead to earlier diagnosis and better treatment for lung cancer, which is a major health challenge in the UK.

At a glance

Status
Recruiting
Sponsor
Royal Marsden NHS Foundation Trust
Enrolment target
500
Start
07 Apr 2021
Estimated completion
01 Jan 2031

What is this study about?

Lung cancer is one of the most common and serious cancers in the UK. Unfortunately, it's often caught at a later stage, which makes it harder to treat. However, more people are now having CT scans, sometimes for other reasons, and also through new lung health checks. These scans often pick up small spots or shadows in the lungs, called nodules. Most of these nodules are harmless, but some can be early signs of cancer. This can be a worrying time for patients and creates a challenge for doctors to work out which nodules need closer attention.

Currently, doctors use guidelines and risk scores to decide if a nodule needs to be monitored or investigated further, often with more scans or a biopsy. This study, called NIMBLE, is looking for better ways to make these decisions. It's using advanced computer techniques, like artificial intelligence (AI) and machine learning, to analyse both blood test results and detailed information from CT scans. The goal is to see if these technologies can help tell the difference between harmless nodules and lung cancer more accurately.

Specifically, the study is interested in nodules found in people who have had cancer before. It wants to learn if AI can help determine if a new cancerous nodule is a spread from their previous cancer or a brand new lung cancer. By doing this, NIMBLE hopes to develop a more reliable and quicker way to diagnose lung cancer early, especially when nodules are first found. This could reduce anxiety for patients with harmless nodules and ensure those with cancer get the right treatment sooner.

Key takeaways

  • NIMBLE uses AI to improve lung nodule diagnosis.
  • Aims to distinguish harmless nodules from lung cancer.
  • Especially important for those with a past cancer history.
  • Involves analyzing blood samples and existing scan data.
  • Could help diagnose lung cancer earlier for better treatment.

Who may be eligible?

To be considered for the NIMBLE study, you need to be an adult (age 18 or older) and currently undergoing checks or monitoring for a lung nodule that was recently found. You wouldn't be able to join the study if you've been diagnosed with any type of cancer in the last five years, or if you're unable to give your informed consent to take part. This means you need to clearly understand what the study involves and agree to participate. Also, if you have an active infection, such as tuberculosis or a fungal infection, or if you've recently had (within the last four weeks) suspected or confirmed COVID-19, you wouldn't be eligible 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 18 years old or older?
  2. Are you currently having checks for a newly found lung nodule?
  3. Have you NOT been diagnosed with cancer in the last 5 years?
  4. Do you feel able to understand and agree to take part in a study?
  5. Do you NOT have an active infection (like TB or a recent COVID-19 infection in the last 4 weeks)?
Answer every question to see your result.

What does participation involve?

The description for taking part in the study is brief. It mentions the study will collect blood samples and analyse routinely collected data that is already part of your patient care. This suggests that if you are eligible and agree to take part, the main components would likely involve providing blood samples. The study will also use information from your existing medical records and CT scans. The exact number of visits, additional assessments, or specific medication is not detailed in this summary. The total duration of your involvement isn't specified, but it's a 'prospective study' which means it will follow participants over time.

Potential risks and benefits

Taking part in this study may not offer direct personal benefits, but it contributes to valuable medical research that could lead to earlier and more accurate lung cancer diagnosis for future patients. Potential risks would likely be minimal, mainly related to blood sampling, such as temporary discomfort or bruising. You would be fully informed about any specific risks before agreeing to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Barking Havering and Redbridge University Hospitals NHS Trust
    Verified postcode
    Goodmayes, United Kingdom· Recruiting
  • Calderdale and Huddersfield NHS Foundation Trust
    Verified postcode
    Huddersfield, United Kingdom· Recruiting
  • Princess Alexandra Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Whittington Health NHS Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • University College London Hospitals NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Guy's and St Thomas' NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Marsden Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Northumbria NHS Foundation Trust
    Verified postcode
    Newcastle upon Tyne, United Kingdom· Recruiting
  • Nottinghamshire Healthcare NHS Foundation Trust
    Verified postcode
    Nottingham, United Kingdom· Recruiting

Common questions

What is a lung nodule?

A lung nodule is a small spot or shadow that shows up on a lung scan. Most of these are harmless, but some can be an early sign of cancer.

What is Artificial Intelligence (AI) in this study?

AI, or artificial intelligence, is like a very smart computer program that can learn from lots of information (like your scans and blood tests) to help doctors make better decisions more quickly.

Why is this study important for lung cancer?

Lung cancer is often diagnosed late, making it harder to treat. This study hopes to find new ways to detect lung cancer earlier, especially when only small nodules are present, which could save lives.

Will I get my test results from the study?

The study aims to develop new methods rather than provide immediate individual results. You should discuss your personal medical results with your own doctor.

What does 'prospective study' mean?

A 'prospective study' means researchers will follow a group of people over time, collecting information as events happen. In this case, they will monitor people with lung nodules to see how they develop.

How to find out more

Sejal Jain

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 "Nodule IMmunophenotyping Biomarker for Lung Cancer Early Dia…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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