RecruitingNAINTERVENTIONAL

Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway

This research aims to find better ways to spot lung cancer early in people who've smoked and have conditions like heart disease or chronic bronchitis. Researchers are studying blood and stool samples, as well as low-dose CT scans, to identify specific biological signs (called biomarkers) that could indicate a higher risk of lung cancer. Finding cancer early often means treatments are more successful. The study also offers help for people who smoke to quit, or support for those who have already stopped. It involves minimal risks and helps build knowledge that could lead to improved screening and care for many people in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

750

Start

02 Apr 2024

Estimated completion

01 Jul 2029

What is this study about?

This study is trying to find new and earlier ways to detect lung cancer, especially in people who have smoked and might also have heart problems related to smoking, or other smoking-related conditions like chronic bronchitis. We know that finding lung cancer early often gives the best chance for successful treatment. Currently, doctors often use special X-rays called low-dose CT scans to look for changes in the lungs.

Now, researchers are also hoping to find 'warning signs' in blood or stool samples. These signs, called biomarkers, could help doctors know who needs a closer look, even before a CT scan shows anything obvious. The study builds on previous research where blood and stool samples were collected from people at risk and some were found to have lung cancer. By comparing those with cancer to those without, researchers identified some promising biomarkers.

To see if these biomarkers truly work, this new study will follow more people. Participants will have blood and stool samples collected, and they'll get a low-dose CT scan of their chest. If you currently smoke, the study will also offer support to help you stop. The overall goal is to improve how we screen for lung cancer, making it easier to find and treat it at its earliest stages.

Key takeaways

Aims to find new ways to detect lung cancer early.
Looks for 'warning signs' in blood and stool samples.
Includes a low-dose CT scan for lung checks.
Offers support for quitting smoking if you need it.
Focuses on people with a history of smoking and related health issues.
Important for improving future lung cancer screening and treatment.

Who may be eligible?

This study is looking for people generally aged between 45 and 80 who have smoked for a significant period. You might be eligible if you have certain smoking-related health conditions, even if you've stopped smoking.

Specifically, you could be considered if you have heart or blood vessel disease linked to smoking (like problems with your arteries or a high calcium score in your heart's arteries). You might also qualify if you have other smoking-related issues like chronic bronchitis, or if you've had certain cancers in the past but have been clear of them for more than five years.

There are also specific smoking history requirements, for example, having smoked daily for at least 10 years, or other criteria similar to those used in large lung cancer screening studies. You wouldn't be able to join if you've had cancer in the last five years (except for very specific types like certain skin cancers), or if you are pregnant or breastfeeding.

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 between 45 and 80 years old?
Have you smoked daily for at least 10 years at some point in your life?
Do you have heart/blood vessel disease linked to smoking, or chronic bronchitis?
If you've had cancer, was it more than 5 years ago (and not specific types)?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide some blood samples and a stool sample. You'll also have a low-dose CT scan of your chest to look at your lungs. This scan doesn't involve any injections. The study will mainly involve these tests to understand your health profile.

If you are currently a smoker, the study team will offer you support and advice on how to quit smoking. If you've already quit, they might offer help to keep you smoke-free. The total duration of your participation in the study is considered to be quite minimal in terms of demands on your time, largely focusing on the initial assessments.

Potential risks and benefits

Taking part in this study has few risks, similar to routine check-ups. The low-dose CT scan uses a small amount of radiation, which is very common and generally safe. The main benefit is helping researchers find better ways to detect lung cancer earlier, which could improve treatments for many people in the future. There's also the potential benefit of getting support to stop smoking if you need it. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Assistance Publique Hopitaux de Marseille
Verified postcode
Marseille, France· Recruiting

Common questions

What is a 'low-dose CT scan'?

It's a special type of X-ray that takes detailed pictures of your lungs with a very small amount of radiation, making it safer for screening.

What are 'biomarkers'?

Biomarkers are tiny signs in your body, like in your blood or stool, that can show if you have a certain condition or a higher risk of developing one, like cancer.

Will I find out my personal test results?

The study focuses on research, so individual biomarker results might not be available. However, any clinically significant findings from your CT scan would be shared with you and your doctor.

Do I have to quit smoking to be in the study?

No, you don't have to quit smoking to join, but if you do smoke, the study will offer support to help you quit.

How long will the study last for me?

Your direct involvement for tests like blood samples, stool collection, and the CT scan is fairly brief, focusing on the initial assessments.

How to find out more

Amandine ROLLAND-BRUN

amandine.rolland@ap-hm.fr 491381245 Official trial record

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