Methodology

Every year in the Netherlands around 1500 children are born with congenital heart disease. The past 40 years, life expectancy of patients with congenital heart disease greatly improved in particular by developments in the field of cardiac surgery. Despite the fact that the majority of these patients had surgery at a young age, remains in many cases life-checking with the cardiologist is necessary because in some patients long-term complications may arise.

It is unknown how many adult patients with congenital heart disease exactly in the Netherlands are born. We also know of many - mostly operated - defects not how the course will be long term. The Dutch Heart Foundation and the Netherlands Heart Institute have jointly initiated a registry and DNA bank of adults with congenital heart disease. The CONCOR-registration is set up to identify how many adult patients with congenital heart disease in the Netherlands live and what problems may arise in the longer term. By existing knowledge and expertise together to care for these patients improve in future.

Purpose of the CONCOR registration:
The CONCOR registry was set up to make an inventory of how many adult patients with a congenital heart defect live in the Netherlands and what problems may arise in the longer term. By combining existing knowledge and expertise and collecting new knowledge, care for these patients can be improved in the future. Every year approximately 1500 children are born in the Netherlands with a congenital heart defect. Over the past 40 years, the life expectancy of patients with a congenital heart defect has improved dramatically, mainly due to advances in cardiac surgery. Despite the fact that the majority of these patients have had surgery at a young age, in many cases lifelong monitoring by the cardiologist remains necessary because long-term complications can arise in some patients.

What is registered:
The CONCOR registration includes personal data such as name, gender, date of birth, center where you were last treated and data regarding diagnoses and interventions (e.g. operations).
To ensure that this information remains up to date (follow-up), CONCOR will regularly request the latest letter from your cardiologist. We ask for your permission to collect and use this data.

How to join the registration:
You can participate in the CONCOR registration by signing the declaration of consent and sending it to us, or by filling in the form on the website. You hereby waive any intellectual property or proprietary rights to patient data and patient material. If you do not grant permission to participate in the registration, this will not affect your further treatment. Participation in the registration is completely voluntary

Withdraw permission:
You can always withdraw your consent for the use of your personal data.Your research data will be destroyed after withdrawal of your consent.If the data has already been analyzed, those results will still be used.

Your privacy is protected:
To protect your privacy, your data is given a code. Your name and other information that can directly identify you are omitted. Data can only be traced back to you with the key of the code.
The key to the code remains securely stored in the local research facility. The data sent to the researchers or other involved parties only contains the code, but not your name or other data that could identify you. Also in reports and publications about the research, the data cannot be traced back to you.

To protect the data, a privacy policy has been drawn up for this registration. This describes your rights and our obligations. A Supervisory Committee has also been appointed that supervises the registration and correct compliance with the regulations.

 Who does have access to your data?
Some people can get access to all your data. Persons who have access to your data for inspection are inspectors from the AMC and the national supervisory authorities, such as the Health and Youth Care Inspectorate (IGJ). They keep your details secret. CONCOR uses an anonymous link with Statistics Netherlands (Central Bureau of Statistics) and other healthcare registries (such as the Netherlands Cancer Institute). We also ask you to give permission for this on the consent form.

For questions or complaints about the handling of your personal data:
You can contact the data protection officer of the AMC via fg@amc.nl
or with the Dutch Data Protection Authority via Autoriteit Persoonsgegevens.nl/over-privacy/informatie.

If you want to speak with an independent doctor:
If you would like to discuss the CONCOR project with an independent physician, please contact Mrs. Dr. M.M. Vis, cardiologist Amsterdam UMC, location AMC, phone 020-5668306.

 

Information about the DNA bank CONCOR:

In recent years, interest in genetic causes of congenital heart defects increased. The DNA is the substance in the body where the genetics are recorded. This DNA is present in all cells of the body and potentially the same everywhere. With modern techniques it is possible to search for the genetic basis of congenital heart defects. Results from these studies may have clinical consequences in the future: -Knowledge of the genetic causes of congenital heart defects may result in patients with congenital heart disease who have a child to get better informed about the risk of repetition ("genetic counseling"). -Possibly the knowledge of the genetic background of congenital heart defects in the future lead to changes in treatment of patients with congenital heart disease

 

Why a CONCOR DNA bank?
The aim of the CONCOR DNA bank is to facilitate scientific research into the hereditary backgrounds of congenital heart defects. Research will focus on the possible relationship between clinical data/diagnoses (as included in the CONCOR registration) and specific hereditary characteristics (by examining the DNA). Research will only be carried out into the causes of congenital heart defects and not into other hereditary diseases or characteristics. DNA of patients who have given permission for this will be stored in this biobank.

Want to participate in DNA testing?
If you decide to participate in the registration, you can also give permission to
1 tube of blood to be drawn. It is also possible to participate in the registration without taking blood.
However, it is not possible to participate in the DNA bank if you have not given permission for registration. If you do not grant permission to participate in the DNA bank, this will have no consequences for your further treatment. Participation in the DNA bank is completely voluntary.

Why should i have blood drawn?
You have a congenital heart defect for which you may or may not have had surgery in the past.
In recent years, interest in hereditary causes of congenital heart defects has increased sharply. The DNA is the substance in our body in which the hereditary properties are recorded.
Modern techniques make it possible to search for the hereditary basis of congenital heart defects. Results of these studies may have consequences in the future:
• Knowledge about the hereditary causes of congenital heart defects can mean that patients with a congenital heart defect who want to have a child themselves can be better informed about the chance that the child will also have a heart defect.
• Knowledge of the hereditary backgrounds of congenital heart defects may lead to changes in the treatment of patients with congenital heart defects in the future.

You want to participate:
You can participate by signing the consent form and returning it to us or fill in the form on the website.
The blood test can possibly be combined with an existing appointment with your own cardiologist.
You do not need to come to another hospital for this. It may take some time before the blood can be drawn from you, this is not a problem. Data from the CONCOR DNA bank will be linked to the CONCOR registry.

Retention period:
Your DNA will be stored within the CONCOR DNA Bank for 50 years. In genetic research it is important to have a picture of several generations.

What do we do with findings that emerge from scientific research with your DNA and that may be of importance to you personally or to your relatives?
It cannot be ruled out that during future scientific research with your DNA matters will arise that are important for your health and/or the health of your family members. You should then think of findings that point in the direction of a disease or condition or an increased risk thereof, eg caused by a hereditary abnormality that can also occur in your family members. We will notify you of such findings if they indicate a serious health problem or risk for which treatment is available. We will always carefully consider whether it is really necessary to inform you of such a finding. In that context, we request advice from a hospital committee that contributes ideas about this.
If you do not wish to be informed, you cannot participate in the CONCOR DNA bank.

You want to participate:
You can participate by signing the consent form and returning it to us or fill in the form on the website.
The blood test can possibly be combined with an existing appointment with your own cardiologist.
You do not need to come to another hospital for this. It may take some time before the blood can be drawn from you, this is not a problem. Data from the CONCOR DNA bank will be linked to the CONCOR registry.

Retention period:
Your DNA will be stored within the CONCOR DNA Bank for 50 years. In genetic research it is important to have a picture of several generations.

What do we do with findings that emerge from scientific research with your DNA and that may be of importance to you personally or to your relatives?
It cannot be ruled out that during future scientific research with your DNA matters will arise that are important for your health and/or the health of your family members. You should then think of findings that point in the direction of a disease or condition or an increased risk thereof, eg caused by a hereditary abnormality that can also occur in your family members. We will notify you of such findings if they indicate a serious health problem or risk for which treatment is available. We will always carefully consider whether it is really necessary to inform you of such a finding. In that context, we request advice from a hospital committee that contributes ideas about this. If you do not wish to be informed, you cannot participate in the CONCOR DNA bank.

Participate in further research:
It is possible that during an examination a variation is found in your DNA, of which it is not clear whether this has any meaning and whether it is related to the development of your heart defect. It may then be desirable from a scientific point of view to conduct further research into this. We ask you whether you agree that you will then be approached by your attending cardiologist to participate in that study.
You will then receive further information and can then decide whether or not to participate in the further investigation.

Cooperation with other centers outside the EU:
It is possible that in the future your DNA and (coded) data will be forwarded to countries outside the EU for cooperation with other medical centers. In those countries the EU rules to protect your personal data do not apply and the level of privacy protection may be less. If you do not want your DNA and data to be released to countries that do not have an equivalent level of privacy protection, you can indicate this on the consent form.

Cooperation with commercial parties:
It is also possible that in the future your DNA and (coded) data will be used for conducting scientific research in collaboration with/by commercial parties. This must be submitted in advance to the Biobank Assessment Committee of the AMC. If you do not want your DNA and data to be released to commercial parties for research, you can indicate this on the consent form.

Withdraw permission:
You can always withdraw your consent for the use of your body material and personal data.
Your body material and your research data will be destroyed after withdrawal of your consent.
If measurements have already been made with your body material and analyzes with the data, those results will still be used.

Your privacy is protected:
To protect your privacy, your body material and data are given a code. Your name and other information that can directly identify you are omitted. Data can only be traced back to you with the key of the code. The key of the code remains safely stored under the responsibility of the administrator of the biobank. Body material and data sent to other researchers only contain the code, but not your name or other data with which you can be identified. The data cannot be traced back to you in reports and publications about the research with your body material.
Privacy regulations have been drawn up for this DNA bank. This describes your rights and our obligations.
The Biobank Review Committee ensures that we comply with these regulations.