Background:
Pediatric differentiated thyroid carcinoma (ped-DTC) is a rare disease, but it is the most common endocrine malignancy in children, representing 2–4% of all pediatric cancers.
While survival is excellent (>98% at 10 years), more than 35% of patients experience treatment-related complications. Current treatment protocols may therefore lead to overtreatment, especially in low- and intermediate-risk patients (~70% of all cases).
At present, reliable tools to predict which children are at higher risk for persistent or recurrent disease are lacking. Adult-based systems (e.g. ATA 2015) are insufficiently accurate for pediatric populations.
Aim of the Ped-DTC STRATIFY Study
The Ped-DTC STRATIFY Study, linked to the European Ped-DTC Registry, aims to develop and validate a prediction model that stratifies children with DTC into high- and low-risk groups for recurrence or persistence of disease within two years of follow-up.
This model will combine clinical, histological, radiological, nuclear, and genetic data to guide individualized treatment decisions and reduce unnecessary interventions.
Initiating center
This study is initiated by the University Medical Center in Utrecht, The Netherlands.
Study Design
- Type: European multicenter prospective observational cohort study
- Population: Children <18 years with histologically confirmed DTC
- Exclusion: Medullary or anaplastic thyroid carcinoma
- Sample size: ~200 patients over two years
- Inclusion period: Histologically confirmed diagnosis between October 1 2024 and October 1 2026
- Follow-up: 24 months after diagnosis
Data Collection
Participating centers enter data via the web-based ped-DTC Registry on the CORE Registry website.
Collected data include:
- Demographics and medical history
- Preoperative ultrasound and cytology findings
- Surgical and histopathological results
- Radioactive iodine treatment details
- Outcomes (recurrence, persistence, complications)
Central review will be performed for:
- Ultrasound imaging
- Postoperative I-131 scans
- Additional scans performed in case of suspected persistence or recurrence of disease
- Histopathology
- Molecular/genetic analyses (including BRAF, RAS, RET, and NTRK variations/fusions) of the thyroid tissue
Objectives
Primary objective:
- Develop and internally validate a prediction model for persistent or recurrent disease within two years after diagnosis.
Secondary objectives:
- Determine prevalence of recurrence/persistence of disease within 2 years after diagnosis
- Assess prevalence of key oncogenic variations (RAS/BRAF/RET/NTRK)
- Compare predictive accuracy (C-index) of the new model with ATA 2015 classification
Participation and Center Involvement
If your center treats pediatric patients with DTC:
- Confirm whether your institution is already participating in the ped-DTC Registry.
- If not, your center can apply to join the registry and participate in the Ped-DTC STRATIFY Study.
- Participation involves no protocol-driven interventions beyond standard care since it is an observational study.
- Data entry and sample sharing are handled under local ethics approval and GDPR compliance.
Participating clinicians identify eligible patients, obtain informed consent, enter data through the Registry, and send the imaging and tissue to the initiating center (University Medical Center, Utrecht, The Netherlands).
Contact for Study Participation
For more information or to join the Ped-DTC STRATIFY study as a participating center:
Contact:
Project coordinator:
Dr. S.C. Clement
s.c.clement-2@umcutrecht.nl
