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, who represent approximately 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, such as 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 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: Approximately 200 patients over three years
- Inclusion period: Histologically confirmed diagnosis between October 1, 2023 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
- Demographics and medical history
- Preoperative ultrasound and cytology findings
- Surgical and histopathological results
- Radioactive iodine treatment details
- Outcomes, including recurrence, persistence, and complications
Central Review
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
Genetic Analyses
Molecular/genetic analyses of the thyroid tissue will be performed, including BRAF, RAS, RET, and NTRK variations/fusions.
Objectives
Primary Objective
To develop and internally validate a prediction model for persistent or recurrent disease within two years after diagnosis.
Secondary Objectives
- Determine the prevalence of recurrence or persistence of disease within two years after diagnosis
- Assess the prevalence of key oncogenic variations, including RAS, BRAF, RET, and NTRK
- Compare the predictive accuracy, measured by C-index, of the new model with the 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, please contact:
Project coordinator:
Dr. S.C. Clement
s.c.clement-2@umcutrecht.nl