All studies
RecruitingOBSERVATIONAL

DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution

This study, called DOLCE, is looking at how a new computer program using Artificial Intelligence (AI) can help doctors manage lung lumps (pulmonary nodules). These lumps are often found by chance on CT scans. The study wants to see if doctors using this AI tool make better decisions about care, leading to better health for patients and potentially saving money, compared to how these lumps are usually managed now. It's a real-world study, observing how things happen in different hospitals.

At a glance

Status
Recruiting
Sponsor
Nottingham University Hospitals NHS Trust
Enrolment target
2,000
Start
23 Mar 2023
Estimated completion
01 Aug 2025

What is this study about?

Imagine you've had a scan, perhaps for something else, and doctors notice a small spot or lump in your lung. These are called pulmonary nodules. Most of the time, these lumps are harmless and not cancer. However, doctors need to carefully watch them to make sure.

This study, called DOLCE, is looking into a new tool that uses Artificial Intelligence (AI) – like a very smart computer program – to help doctors decide what to do next. The computer program helps predict if a lung lump is more likely to be serious or not. The study wants to see if doctors using this AI tool can make quicker, more accurate decisions about your care compared to the usual way they manage these lumps.

The main goal is to find out if using this AI tool leads to better health results for patients and is a more efficient way to manage these lung lumps overall. Researchers will be observing what happens in several different hospitals, comparing the results of patients whose doctors use the AI tool with those whose doctors follow the standard way of caring for these lumps.

Key takeaways

  • The study investigates an AI tool to help doctors manage lung lumps.
  • It aims to improve patient health and show cost-effectiveness.
  • Participation involves allowing researchers to gather information from your standard medical care.
  • You won't receive new treatments specifically for the study.
  • You must be at least 35 years old and have a specific type of lung lump to be eligible.
  • You can withdraw from the study at any time without affecting your normal medical care.

Who may be eligible?

You might be able to join this study if you are 35 years old or older and have had a CT scan that showed a lung lump between 5mm and 30mm in size. This lump shouldn't be fully hard and chalky, and it should be clearly visible on the scan.

However, you won't be able to join if you've had a cancer diagnosis in the last five years, or if you have metal implants in your chest that might affect the scan pictures of your lung lump. You also can't join if you have many lung lumps (more than five) or if you're already receiving care for another lung lump that is very large or appears as a pure hazy spot.

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 35 years old or older?
  2. Do you have a lung lump found on a CT scan that is between 5mm and 30mm?
  3. Have you NOT been diagnosed with cancer in the last 5 years?
  4. Do you NOT have more than five lung lumps in total?
  5. Are you NOT currently being monitored for another large or hazy lung lump?
Answer every question to see your result.

What does participation involve?

This is an observational study, which means you won't be given any new treatments or medicines specifically for research purposes. Instead, the study will simply follow your usual medical care for your lung lumps. Researchers will collect information from your existing medical records, especially details from your CT scans. You'll continue to have your appointments and follow-up scans as recommended by your doctor, according to standard practice. The study isn't changing your care; it's looking at how doctors make decisions using or without the AI tool. The total duration of your participation will depend on how long your doctor typically monitors your lung nodule.

Potential risks and benefits

The main benefit of taking part is that your doctor might be using a new AI tool to help them make decisions about your care, which could potentially lead to more precise management of your lung lump. Since this is an observational study, there are no additional medical risks from new treatments or procedures. All your care decisions will still be made by your doctor. You can withdraw from the study at any time without it affecting your medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Betsi Cadwaladr University Health Board
    Verified postcode
    Bangor, United Kingdom· Recruiting
  • Frimley Health NHS Foundation Trust (Wexham Park Hospital)
    Verified postcode
    Frimley, United Kingdom· Recruiting
  • Leeds Teaching Hospitals NHS Trust
    Verified postcode
    Leeds, United Kingdom· Recruiting
  • King's College Hospital NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Free Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • St. George's University Hospitals NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • The Royal Marsden NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • University College London Hospitals NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Nottingham University Hospitals NHS Trust
    Verified postcode
    Nottingham, United Kingdom· Recruiting
  • Oxford University Hospitals NHS Foundation Trust
    Verified postcode
    Oxford, United Kingdom· Recruiting

Common questions

What is a 'pulmonary nodule'?

It's a small spot or lump found in the lung, often on a scan. Most are harmless.

What is 'AI'?

AI stands for Artificial Intelligence. It's a computer program designed to help doctors make decisions.

Will I get a new treatment in this study?

No, this study just observes your usual care. You won't receive different treatments because of the study.

Will my doctor use the AI tool for my care?

The study is comparing care with and without the AI tool. Your doctor will know if they are using it.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time, and it won't affect your medical care.

How to find out more

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 "DOLCE: Determining the Impact of Optellum's Lung Cancer Pred…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.