For each patient, the registry collects a basic set of data. In the future, approved linked studies requiring specific data collection can be added to the database. Patient demographic and clinical data are submitted by sites via direct data entry using a secured web-based database. The primary physician/site investigator is responsible for entering patient data directly into the database. Sites will be trained to use the database and will be provided with a data entry manual to assist with good-quality data collection. Data to be collected in the basic ped-DTC registry include the following domains: (i) demographics; (ii) preoperative results; (iii) surgical treatment; (iv) postoperative results; (v) 131I therapy; and (vi) outcome. Data items collected by the basic ped-DTC registry are outlined in Table 2. A detailed case report form (CRF) will be developed by the expert working group.

Data items collected by basic pediatric-DTC registry.

1. Patient details2. Preoperative3. Surgical treatment4. Postoperative5. (131I) therapy6. Outcome
Patient IDPresence of comorbiditiesSurgeon (pediatric/ adult/ endocrine/ combination)TNM stagingIndicationSerum Tg antibodies
SexFamily history of DTCProcedure typeHistology (PA)Number of 131I treatmentsMaximum stimulated Tg
Date of enrollmentTypical manifestations of familial syndromesIndication for procedureGenetic testing resultsCumulative activity of 131IDeath of disease
Country/hospitalPrevious exposure to radiationLymph node dissection (levels)Transient hypoparathyroidismDistant metastasesDeath of any cause
Age at diagnosisPrevious malignancyLymph node dissection intentTransient recurrent nerve injuryDistant metastasis sitesDate of death
Date of diagnosisPrevious thyroid surgeryOther adverse events/surgical complicationsOther adjuvant therapy (i.e. radiotherapy or TKI)Date of last known alive
Clinical symptomsRecurrence
Dominant finding at physical examPersistent disease
Thyroid function at diagnosisRemission
Preoperative imaging resultsPersistent hypoparathyroidism
Results of fine needle aspiration (Bethesda classification)Persistent recurrent nerve injury
Clinical voice abnormalityDry mouth/hyposalivation
Preoperative laryngeal examSecond primary malignancies
Weight SDSInfertility
Height SDSOther adverse events
Calculated BMI SDS

BMI, body mass index; DTC, differentiated thyroid carcinoma; PA, pathology; SDS, standard deviation scores; Tg, thyroglobulin; TKI, tyrosine kinase inhibitor; TNM, tumor, node, metastases.