Frequently Asked Questions

You can only participate in case you can read and understand Dutch, as the informed consent form is currently only available in Dutch. You can find more details on the Dutch section of the website, click here if you want to go there.

Patients should be asked and informed when they participate in the DuTOC project. After signing the informed consent form, the patient will be registered once via a web-based registration. These registration details will be used for linking to the Netherlands Cancer Registry (NKR). The questionnaires will be sent out via an application, if permission has been given. You do not need to do anything for this, this will all be arranged for you.

Yes, it is possible for your patient to participate in another observational or interventional study at the same time, because the DuTOC does not prescribe any obligations regarding treatment, lifestyle or diagnostics. Only the actual treatment is registered for the DuTOC project. However, this can of course chance if a patient participates in an interventional substudy.

Data from patients who participate in other studies are also included in the NKR. And an application can always be submitted via the NKR that concerns study participants. Since the DuTOC collects data which is included in the NKR, there is no difference. Just like with the NKR, an application will also be thoroughly assessed via the DuTOC scientific committee. So that, among other things, no conflicts arise. Moreover, this thorough assessment is also in the interest of DuTOC itself.

No, for a TwiCs study it is necessary to submit a study protocol separately to the METC and receive METC approval. This way you will always be informed when a TwiCs study is running within your center.

In the web-based registration application it is possible to view the data from your patients. Patients from other centres are not visible.

Yes, this study has been approved by the METC NedMec.

Yes, you can. Whether or not you can store samples is not a requirement for hospitals to participate in the DuTOC project.

Certainly. Patients can participate at time they start their treatment, but patients who have already started can also participate.

All patients aged 18 years or older within the participating hospitals diagnosed with a pathological thoracic malignancy or recently diagnosed with strong suspicion but without pathological confirmation but with confirmation from the MDO (multidisciplinary board), with preferably a treatment wish.

Samples that are stored at pathology, collected via diagnostics, can be requested by anyone. So this is not DuTOC specific. DuTOC can submit a request for fresh frozen materials. After payment, DuTOC will be the owner and materials will be released. After that the materials can be transported outside the hospital for research and analysis. However, DuTOC has no insight into what is in your own biobank. So if we do not know, we cannot request it. Unless agreements have been made about requesting samples from your own biobank, but this is always done in consultation.

In addition, the physician/hospital knows whether a substudy is running via a TwiCs design. Besides signing the Informed Consent Form (ICF) for the substudy by the patient, approval from the METC is required. As a result, the hospital and physician are aware that the substudy is running in their hospital. And there is ofcourse the possibilities that a hospital denies to participate in that specific substudy.

DuTOC aims to improve the quality of life and survival of lung cancer patients. By being able to give patients even better tailored treatment. The data we collect within this project can provide interesting insights for different parties, such as researchers, healthcare institutions, patient representation and companies.

To use the collected data, these parties submit a research proposal to DuTOC. DuTOC’s scientific committeee valuates this application to see if it fits the DuTOC goal. So would this research help lung cancer patients? Or will this research provide new drugs or treatment options for example. Or would it give us more information about a particular drug?

All data will remain confidential. To protect the patients privacy, we give the data a unique study code as soons as a patient is registered in our secure study database. We put only this study code on all collected data. Also when we process data and samples we always use only the code. In reports and publications about the study, no one can therefore find out to wich patient it belongs.

To protect privacy, we give data a unique study code upon registration in our secure study database. On all data, we put only this study code. Tissue samples and blood are also given this study code, if consent has been given for these study components. We keep the key to the code in a secure place at the participating hospital and in the secure study database.

A list of participating hospitals can be found here

If consent is given, we collect, use and store already collected blood, tissue and other body material (e.g. saliva).
In addition, patients can be asked to donate an extra tube of blood during a blood draw.

In addition to personal data, such as name, postal code, e-mail address, age and gender, which are only needed to link DuTOC to the already existing registers. We collect the following medical examination data, among others:

• data about the tumour
• imaging (lung photos and scans)
• laboratory values
• details of the treatment and its outcome. As well as any side effects.
  

Yes, you can. You can email your proposal to DuTOC@umcutrecht.nl after which it will be discussed by the scientific committee.

Any researcher can submit a research proposal. Before sharing any data, the scientific committee reviews the research proposal to see if:

• it is of sufficient quality;
• whether the research question can reasonably be answered;
• if a similar research is not already in progress;
• if the privacy of patients and participating hospitals is sufficiently guaranteed.

Participating hospitals can always view their own data in the web-based submission application.

When participants give their consent to complete questionnaires, this data is stored in the Profile system.
We also collect personal data such as name, postcode, email address, age and gender. This personal data enables us to link with existing registers, such as NKR and DICA.