If molecular analyses are performed in our center, will the initiating center cover the costs?

Yes, if molecular analyses are performed locally in the participating center for the purpose of the Ped-DTC STRATIFY Study specifically (instead of sending tissue to the central lab), the initiating center will cover the associated costs, as these analyses were initially budgeted to be performed locally. The costs for the molecular testing will therefore be reimbursed from this budget. We kindly ask you to send us a cost overview in advance, before performing the molecular analyses, so that we can review and confirm the reimbursement arrangements.

Our center already performs genetic testing. Can we simply share the results with you instead of sending tissue samples?

We prefer to receive the tissue samples for centralized analysis whenever possible, to ensure consistency across the study. However, if sending tissue for molecular analyses is truly not feasible, we are open to using the molecular testing results from your center. In that case, we kindly ask you to email us which genes were tested/ which tests were performed, as well as the protocol used, including the platform and the name of the laboratory. We also ask that the test results be entered into the Ped-DTC Registry to ensure complete documentation, if the patient gave permission for this on the informed consent form. Based on the information you provide, our team will internally assess whether the patient can be included in the postoperative prediction model.

Linked Studies

The ped-DTC Registry also acts as an umbrella platform. Hospitals can propose linked studies, for example prospective studies or clinical trials, to collect additional data. Every linked-study proposal is reviewed by an expert working group to ensure high-quality and standardized research. Participation in any linked study always requires separate consent from the patients and families.

View studies

Step-by-step process for a linked study in the ped-DTC Registry

Linked studies

Frequently asked questions

Can all pediatric patients with thyroid cancer be included, or is the study limited to differentiated thyroid carcinoma only?

The study is limited to patients with differentiated thyroid carcinoma (DTC) only. Other types of thyroid cancer are not included in the Ped-DTC STRATIFY Study.

Can we receive an official invitation letter for the Ped-DTC STRATIFY Study?

Yes, we can provide an official invitation letter for the STRATIFY Study upon request, if needed for your local ethics committee. Please contact the study team directly to receive the official invitation letter. Provide the name and title of the person/ people the letter should be directed to, as well as the institutions name.

Do I need two separate informed consent forms? One for the Ped-DTC Registry and one for the Ped-DTC STRATIFY Study?

Yes, both an informed consent form for the Ped-DTC Registry and a separate one for the Ped-DTC STRATIFY Study are required.
The Ped-DTC Registry consent forms can be found on the CORE Registry website (https://eurreb.eu/patient-information-folders-consent-forms/). The Ped-DTC STRATIFY consent form has been sent via email. If needed, we’re happy to resend any of the forms; just contact the study team.

How do I include a patient in the Ped-DTC STRATIFY Study?

A: To include a patient, please follow these steps:

1. Get local ethical approval

1. All required documents for ethical approval of the Ped-DTC STRATIFY Study have been sent to you via email. If you are unable to locate them or would like the documents to be resent, please don’t hesitate to contact the study team. We are happy to send them again. If you require any additional documents for your local approval process, we can also provide those upon request.
Check the inclusion criteria for your patient:
a) The patient can be included in the Ped-DTC STRATIFY Study if the diagnosis was made between 1 October 2024 and 1 October 2026 at the age of 18 years or younger.
Obtain informed consent:
Both the registry and STRATIFY require a separate signed informed consent form. These must be signed before the patient can be officially included.
Enter patient data into the Ped-DTC Registry:
Once eligibility and consent are confirmed, the patient’s data should be entered into the Ped-DTC Registry.
A step-by-step explanation is provided in the presentation ‘How to use the Ped-DTC Module’.
Send required imaging and pathology materials:
1. Preoperative thyroid ultrasound must be sent via RIA-eXchange.
2. Also send the post-ablation scan, and any other imaging performed in the context of suspected recurrence or persistent disease through RIA-eXchange.
3. As described in our imaging and pathology FAQs and our lab manual which has been sent to you by email, we also require:
  a) All pathology slides (H&E and IHC) for central review.
  b) Thyroid tissue samples (one representative FFPE block or alternative materials) for molecular analysis.

If you have any doubts or need assistance during the inclusion process, please don’t hesitate to contact the study team.

I just heard from someone else/ discovered on the website that the Ped-DTC STRATIFY study exists, and my center is not yet participating. Can I still join?

We would be very happy if your center could also join. Please feel free to contact the study team to discuss how you can participate. We can send you more information about both the Ped-DTC STRATIFY Study and we can schedule a Teams meeting to discuss everything and answer any questions you may have.

I know another center that might be interested in participating in the study. What should I do?

We’re always open to involving new centers in the study. If you know a center that may be interested, please email our study team with the contact details of the appropriate contact person. We will then reach out to them directly to explore further collaboration.

We don’t have enough time to get everything arranged. Can we get help?

Absolutely. If you’re experiencing time constraints or practical difficulties, Bo Smits (Ph.D-student from the study team) can visit your center in person to provide hands-on support with inclusion, data entry, material collection, or any other steps needed. Additionally, Bo can also assist remotely, for example by helping with data entry in the registry, provided that a 0-appointment (zero-hours contract) can be arranged locally for her and that remote access to the electronic patient records (EPDs) is granted.

Please don’t hesitate to contact the study team to arrange a visit. We’re happy to help wherever and whenever needed.

What are the inclusion criteria for the Ped-DTC STRATIFY Study?

To be eligible for inclusion in the Ped-DTC Stratify Study, the patient must have been diagnosed with paediatric DTC between October 1st, 2024 and October 1st, 2026. In addition, the patient must have been 18 years of age or younger at the time of diagnosis.

What if my patient is 18 years old? Can they still be included?

Yes, patients who are 18 years old at the time of diagnosis can be included. To be eligible, patients must be 18 years of age or younger at the moment of diagnosis of differentiated thyroid carcinoma.

Where can I find the documents to get ethical approval for the Ped-DTC STRATIFY Study?

All required documents for ethical approval of the Ped-DTC STRATIFY Study have been sent to you via email. If you are unable to locate them or would like the documents to be resent, please don’t hesitate to contact the study team. We are happy to send them again.

If you require any additional documents for your local approval process, we can also provide those upon request.

Which centers are participating in the Ped-DTC STRATIFY Study?

An overview of all participating centers will be available on our website.

Frequently asked questions about the imaging

How should I send the imaging data?

We use RIA-Exchange to securely transfer imaging data. A detailed how-to document has been created and shared with all participating centers to guide you through the process.

Imaging was performed in a different hospital/unit, or is only available on a CD held by the patient and not stored in our hospital due to privacy regulations. It’s often difficult to obtain and send these files to your team. What should we do?

We understand that imaging may be stored externally or only available on CD. If you’re having trouble sending the files, please contact our study team; we can help arrange a secure transfer or contact the radiology department directly.

If the thyroid ultrasound images/ other images can really not be obtained, please send us the radiology report. Based on that, we’ll decide whether the patient qualifies for the preoperative and/ or the postoperative model.

We are only able to send imaging data acquired from now on, and not any ultrasounds/ scans taken in the past (even after October 1st, 2024). Is that acceptable for participation in the Ped-DTC Stratify Study?

Yes, that is absolutely fine. If it is only possible to send imaging starting from the moment you actively participate in the Ped-DTC Stratify Study, and not from October 1st, 2024, that is also acceptable. However, in many cases, it might still be possible to retrieve and share earlier scans. Please get in touch with the study team to discuss what may be feasible. Local support from the Ped-DTC Stratify team can be arranged to assist with this if needed.

What imaging is required for the Ped-DTC STRATIFY Study?

The study requires access to all relevant imaging related to the diagnosis, staging, and follow-up of thyroid carcinoma. This includes the pre-operative ultrasound of the thyroid, post-operative radioactive iodine scans (e.g., I-131 scintigraphy), and any additional imaging performed in cases of suspected disease persistence or recurrence. If imaging was performed in an external center, please inform our study team, we can support you in obtaining and securely transferring the necessary files.

Frequently asked questions about the pathology

Are transport costs for sending tissue samples reimbursed by the study?

Yes, the Ped-DTC STRATIFY Study provides a budget to cover transport costs for sending tissue samples and related materials. Please keep all shipping receipts and send them to us for reimbursement. If you have any questions about the process or need guidance on cost coverage, please contact the study team. We aim to make this process as smooth as possible for participating centers.

But what if the surgery was done in another center? Do they also need ethical approval?

In most cases, an MTA is sufficient because the tissue is considered the patient’s property. However, local regulations and requirements may vary. Therefore, if there is any doubt about whether additional approvals (such as ethical approval) are necessary, please contact the study team. We are happy to advise and support you in finding a suitable solution.

Can we send digital images of the pathology instead of the actual tissue samples?

While we understand that sending digital pathology images (e.g., scanned slides) may seem more convenient, the Ped-DTC STRATIFY Study requires original tissue samples whenever possible. This is not only to allow for standardized histopathological review, but also because the tissue (one representative FFPE block) is needed for genetic analyses that are an essential part of the study. If sending the physical samples poses significant logistical challenges, please contact our study team to discuss potential alternatives. In some cases, high-quality digital images may be used for initial review of the slides, but they cannot fully replace the need for original tissue.

Pathology samples are hard to obtain and send to your site, especially when surgery was performed in a different hospital than the primary treatment center. How should we handle this?

We recognize that obtaining pathology materials can be challenging, particularly when surgery was conducted at another institution. Because the tissue technically belongs to the patient, a Material Transfer Agreement (MTA), which we have sent to you by email, can often be used to formalize the transfer of samples. In exceptional cases where more specific arrangements are required, the study team can assist in coordinating these.

To which address should we send the thyroid tissue samples?

The address can be found on the Pathology Form. Please send the thyroid tissue samples, along with the completed Pathology Form and any relevant documentation, to the following address:

Princess Máxima Medical Center for Pediatric Oncology
Ronald de Krijger, pathologist
Laboratory for childhood cancer pathology
Room number: 3‐4F1
Heidelberglaan 25,
3584 CS Utrecht,
The Netherlands
Tel: +31 (0)6 501 73018
e‐mail: Pa-admin@prinsesmaximacentrum.nl

After sending the samples, please email a shipping confirmation to b.e.smits-8@umcutrecht.nl, including the tracking number or Track & Trace code. This helps us monitor the shipment and ensure the samples arrive safely.

If you need any assistance with packaging, labeling, or courier arrangements, please look at the Lab Manual and feel free to contact our study team. We’re happy to support you to ensure proper and secure delivery.

What pathology materials do you need for the study?

Information about the required pathology materials can be found in the Laboratory Manual, which has been sent to you by email. Below is a summary of the key requirements:

Pathology Slides for Central Review

1. 1. We require all hematoxylin and eosin (H&E) stained slides and all immunohistochemically (IHC) stained slides prepared from the thyroid tumor tissue.
  2. There are no strict requirements regarding slide thickness; any routine histological thickness is acceptable.

Tissue Samples for Molecular Analysis

1. For molecular analysis, please provide one representative formalin-fixed, paraffinembedded (FFPE) tissue block per patient.
  1. The block should contain a minimum of 2 cm² tumor tissue with at least 40% tumor content.
  2. Tissue sections should be cut at a thickness of 10 µm for genetic analysis
    1. → If Tumor Area Is Limited; examples:
      1. If only 1 cm² of tumor tissue with ≥40% tumor content is available, cut sections should be 20 µm thick.
      2. If only 0.5 cm² of tumor tissue with ≥40% tumor content is available, cut sections should be 40 µm thick.
2. Alternative if Paraffin Blocks Cannot Be Sent
  1. If the FFPE block cannot be sent, please provide:
    1. 10 unstained slides of tumor tissue, each 4 µm thick, suitable for immunostaining.
    2. 10 scrolls of tumor tissue, each 10 µm thick, placed in labeled Eppendorf tubes (labeled with the Ped-DTC STRATIFY Patient ID), for molecular analysis.

Additionally, please complete the Pathology Form and include the macroscopic details from the pathology report, as this information is essential for our documentation and analysis.

If you anticipate any difficulties in sending the tissue, please don’t hesitate to contact us. We are happy to support you in coordinating the transfer.

Frequently asked questions about the molecular analyses

Linked Studies

Step-by-step process for a linked study in the ped-DTC Registry

Linked studies

Development of a pediatric differentiated thyroid carcinoma registry within the EuRRECa project: rationale and protocol in: Endocrine Connections Volume 12 Issue 3 (2023)

2022 European Thyroid Association Guidelines for the management of pediatric thyroid nodules and differentiated thyroid carcinoma in: European Thyroid Journal Volume 11 Issue 6 (2022)

Personalising treatment for childhood thyroid carcinoma

Frequently asked questions

Frequently asked questions about the imaging

Frequently asked questions about the pathology

Frequently asked questions about the molecular analyses

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