Who can take part?

Screening for lung cancer is mainly useful for people with a high risk of developing lung cancer. Lung cancer is mainly encountered in people who have smoked for a large part of their lives. Are you between 60 and 79? For instance, have you smoked at least 1 pack a day for 25 years? Or perhaps at least 2 packs for 15 years? And if you have stopped smoking, did you do so after 2005? Then you will probably be eligible for the study. 

Am I eligible for the study?

If you have doubts about whether you are eligible, you can also perform a self-test online to see if you may be eligible to take part in the study.

Have you smoked less intensively? Then we expect you to have a lower risk of lung cancer and you may experience more disadvantages by taking part. This means screening is not useful for you at this moment in time. This does not mean you cannot get lung cancer. That is why you should always consult your GP if you suffer symptoms that are associated with lung cancer.

Are you being treated or have you been treated for lung cancer in the past 5 years? Then this study will not be useful for you. You do not have to do anything else.

How can I report that I am interested?

Take your time to read the information on this web page (about participating in the study) before you make a decision. If you want to take part, click the green “I want to take part!” button and fill in the questionnaire online. We will send you an informed consent by post. You can use the accompanying reply envelope to return the signed informed consent (no stamp needed).

The study team will carefully examine the completed questionnaire. The study team will then determine whether you meet all requirements for participation. We will also consider other factors than smoking alone, and will do this using a scientific questionnaire. 

I am eligible to take part
We will contact you if your answers show that you are able to take part. Participation is always voluntary. This means you can stop participating at any moment in time. And there is no need to mention a reason. 

I am not eligible to take part
We will still contact you if your answers show that you cannot take part.  If you are not eligible to take part, this does not mean that you cannot get lung cancer. That is why you should always consult your GP if you suffer symptoms that are associated with lung cancer. 

You do not have to do anything. We will no longer approach you.

What does participation entail?

Take your time to read the information on this web page (about participating in the study) before you make a decision. If you want to take part, fill in the questionnaire online and return the informed consent that you receive by post (no stamp needed). You can become a participant if, due to the answers on the questionnaire, we expect you to have an elevated risk of lung cancer.

All participants will undergo a CT scan of the lungs. This examination takes approximately 10 minutes and is painless. We will divide all participants into two groups prior to the first CT scan. These groups will be formed via a draw. Everyone thus has the same chance of joining each group. It is not possible to switch to the other group. This is the only way for us to compare the groups effectively. You will be sent a letter that tells you in which group you have been placed. 

At some locations, a small amount of blood will also be taken to see if your blood contains substances that could point to lung cancer. So we are asking for your consent to do this.

Below you will find information about what happens if you do or do not want to participate. Please contact us if you have other questions.

The study team will carefully examine the completed questionnaire. The study team will then determine whether you meet all requirements for participation. We will also consider other factors than smoking alone, and will do this using a scientific questionnaire. 

I am eligible to take part
We will contact you if your answers show that you are able to take part. Participation is always voluntary. This means you can stop participating at any moment in time. And there is no need to mention a reason. 

I am not eligible to take part
We will still contact you if your answers show that you cannot take part.  If you are not eligible to take part, this does not mean that you cannot get lung cancer. That is why you should always consult your GP if you suffer symptoms that are associated with lung cancer. 

You do not have to do anything. We will no longer approach you.

Participation in the study is voluntary. You can always drop out of the study, even if you have agreed to participate. There is no need to mention a reason in this case. Whether or not you take part will have no impact on your medical care.

How will we conduct the study?

Step 1: allocation into study groups
Firstly, the computer will allocate all participants into one of two groups. It is not possible to switch between groups. This is the only way for us to compare the groups effectively. You will be sent a letter that tells you in which group you have been placed. 

Step 2: first CT scan of the lungs.
All participants will undergo a CT scan of the lungs. This examination lasts approximately 10 minutes and is painless. You will not receive any medicines for this examination and a contrast medium will not be used. More information about the CT-scan examination can be found in the appendix. The CT scan can be used to look for abnormalities in the lungs that could point to lung cancer. You will receive the result within approximately 3 weeks.

At some locations, a small amount of blood will also be taken to see if your blood contains substances that could point to lung cancer. So we are asking for your consent to do this.

Step 3: the following CT scans in the 2 study groups
All people with a negative test result (no abnormalities) will be automatically invited for a new CT scan. The study group will determine exactly when this is. If (minor) abnormalities are actually found on the CT scan, they will also receive a CT scan every year until the end of the study. If lung cancer is suspected, people will be referred to the lung specialist for further examination. 

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Overview study groups

The study will focus on participants whose first CT scan showed no abnormalities that are suspected to be lung cancer. All participants will be drawn into two groups prior to the first scan.

There are two groups:

Study group 1: in the two following years, participants in this study group will receive a CT scan every year. Therefore, a total of 3 CT scans will be performed on their lungs. 

Study group 2: participants in this study group will receive one CT scan of their lungs after two years.  Therefore, a total of 2 CT scans will be performed on their lungs. 

If abnormalities are actually discovered on the CT scan, you will still receive a CT scan every year. You may also be referred to the lung specialist for further examination.  

More information about the results of the examination can be found here. 

What will we do once all CT scans have been carried out?

Once all CT scans have been carried out, we will ask the Netherlands Comprehensive Cancer Organisation to inform all participants that have lung cancer about the stage and type of cancer. To do so, we need you to provide written approval on the informed consent. You will not be able to take part in the study if you do not want to provide consent for this.

The stages of lung cancer that are found in the two study groups will be compared. In this case, we would like to know whether it is equally safe to invite one of the 2 groups (study group 2) for a CT scan every 2 years instead of every year (study group 1). If there are no stage-related differences in the groups (which is positive), we will be able to increase the period of time between the two CT scans in people where no abnormalities were encountered during the first CT scan.

Coincidental discovery of other serious abnormalities

The CT scan will only show the area around the lungs. We will not look for abnormalities in other organs. However, sometimes the doctor may coincidentally discover another serious abnormality. For example, this could involve cancers other than lung cancer or dilation of the aorta.

Further examination will then be important for your health. But it may also make you feel worried and uncertain. Treating a severe abnormality that is discovered coincidentally can have very intrusive consequences. However, the condition may also be beyond treatment, which means you will know that you are ill, and also know that doctors can do little to assist you.

You are free to decide whether we should inform you if other severe abnormalities are encountered on your CT scan. You can mention this on the informed consent. If you provide consent, the study team will inform your GP about the matter. Your GP will then contact you and refer you to a specialist at the hospital.

Even though you indicated that you do not wish to be contacted if an abnormality is discovered coincidentally, the doctor may still do so. This may be done if the doctor believes that not telling you could be dangerous to your health or the health of people around you. Naturally, the doctor will consider this matter carefully and will not make the decision alone. In this case, advice will be requested from an independent committee. These people will have nothing to do with the study. Of course, these people will not be aware of your identity; they will only see a code.

Extra measurements for scientific research only

The CT scan will show the area around the lungs. Besides lung cancer, the CT scan will also show the degree of artery calcification in the arteries around the heart: this is referred to as ’the calcium score’. The calcium score is an indicator for the risk of cardiovascular disease. We are also able to examine measurements that offer an insight into (chronic) respiratory diseases: “the respiratory lung volume”. The use of these two measurements is something rather new. That is why we will measure and examine these values, but not share them with you or your GP. We first need to conduct more research before we know enough about how these measurements can be used.

An exception will be made for an elevated calcium score because this may require further treatment. Your GP will be informed if you have an elevated calcium score.

More information about participation

It will not cost you anything to take part in the study. We will pay for all examinations that are needed for the study. Namely, the CT scans for which you will be invited. You do not have to pay anything for them and they will also not be charged via your health insurance. You will be able to claim your travel expenses.

For approximately 8 in every 100 participants, the CT scan will show abnormalities that require further examination by a lung specialist. This will no longer be part of the 4-In-The-Lung-Run study. As soon as you consult the lung specialist, all costs will fall under your health insurance. This is also how things were arranged in other population studies in the Netherlands. Further examinations deemed necessary by the lung specialist may be (partly) charged against your deductible. Some medicines are also subject to a personal contribution. 

Your details will be processed in encrypted form. This means we will use a personal study number instead of your name and address. Researchers will only see the study number and will thus never use your name in the articles or reports that they write.  This means researchers cannot know to whom the details belong. 

Your details, like your name and address, can only be accessed by a few members of the study team. This is needed to, for example, invite you for the CT scan or to send the result of the CT scan.

All employees comply with the General Data Protection Regulation and the Privacy Regulations of the Erasmus MC. All information about you will only be used for the 4-IN-THE-LUNG-RUN study. The Medical Treatments Agreement Act (WBGO) stipulates that all data must be retained for a period of 15 years after stopping the study. All data will be destroyed after this period.

The informed consent will ask you to provide the following consent: 

Would you like to take part in the study?: 

Can we monitor information about your name, address details and town/city in the Key Register of Persons (previously the Municipal Basic Administration), so that we can inform you about, for example, the result of the examination? This will also allow us to take into account your death if necessary. In this case, we will not approach your descendants. 

Can we collect 3 vials of blood in order to analyse substances in the blood that could be related to lung cancer? (Depending on location) 

May we share the results of the examination with your GP? 

May we inform your GP if we find something unexpected on the CT scan?

May we request information about your health, which is relevant to this study, from your treating physician and other care providers? 

If necessary, may we ask the Centraal Bureau voor Genealogie and Statistics Netherlands (CBS) for the date and cause of death?

May we ask your healthcare insurer about the medical costs you incurred in relation to your lung cancer? When doing so, none of your (medical) details will be shared with your health insurer. 

May your study data (without name, address and date of birth) be used for other related medical/scientific research? 

All (medical) information will only be used for the 4-IN-THE-LUNG-RUN study. We will not give medical information about you to any of the above-mentioned organisations. Data will also be processed after encryption, which means only a few authorised people will be able to access details like your name, address, etc. Your personal details will only be used for invitations and when informing you about the result of the CT scan.