Thyroid cancer risk and follow-up after childhood radiotherapy

Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy

This project will test whether earlier and regular ultrasound plus genetic testing can detect thyroid nodules and cancers sooner in children treated with radiotherapy.

Quick facts

• Study type: Observational
• Enrollment: 2550 (estimated)
• Ages: 10 Years to 43 Years
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Bologna and 1 other locations)
• Trial ID: NCT07473518 on ClinicalTrials.gov

What this trial studies

This observational study follows children who received radiotherapy before age 18 and compares them with unexposed pediatric controls to determine how often and when thyroid nodules and differentiated thyroid cancer occur. Participants receive early and intensive clinical and ultrasound follow-up and available thyroid lesions undergo genetic analysis on cytology and surgical specimens to look for predictive biomarkers. Researchers will analyze incidence, timing, and risk factors to define optimal surveillance schedules that balance early detection with practicality and patient burden. The genetic findings aim to inform personalized surgical decisions and the potential use of targeted therapies in this post-radiotherapy pediatric population.

Who should consider this trial

Good fit: Children who received radiotherapy before age 18 (between 1999 and 2018) and have at least four years of follow-up at the IRCCS AOU Bologna pediatric endocrine program are ideal candidates.

Not a fit: Children who were never exposed to ionizing radiation or who already have genetic syndromes or autoimmune thyroid disease under existing surveillance may not derive direct benefit from radiotherapy-specific findings.

Why it matters

Potential benefit: If successful, this could enable earlier, more personalized detection and treatment—reducing unnecessary surgery for low-risk findings and improving outcomes for children who develop aggressive tumors.

How similar studies have performed: Previous work has established that childhood radiotherapy increases thyroid cancer risk, and ultrasound surveillance is commonly used, but molecular biomarker testing in this specific pediatric, post-radiotherapy group remains relatively untested.

Eligibility criteria

INCLUSION CRITERIA

For the group of oncologic patients who underwent radiotherapy:

* Radiotherapy for an oncologic condition performed between January 1, 1999, and December 31, 2018;
* Age at the time of radiotherapy \< 18 years;
* Follow-up of at least 4 years conducted at the Endocrine-Metabolic Diseases Program, Pediatric Unit, IRCCS AOU Bologna;
* Obtained informed consent

For the group of subjects not exposed to radiotherapy and without specific risk factors for DTC:

* No history of exposure to ionizing radiation;
* No specific risk factors for DTC (autoimmune thyroiditis, familial forms, genetic syndromes);
* Thyroid ultrasound performed between January 1, 1999, and December 31, 2018, at the Nuclear Medicine Unit of IRCCS AOU Bologna;
* Age at the time of the thyroid ultrasound \< 18 years;
* Obtained informed consent

EXCLUSION CRITERIA:

For the group of oncologic patients who underwent radiotherapy:

* Patients transferred to another center before completing 4 years of follow-up after radiotherapy at the Pediatric Unit of IRCCS AOU Bologna, without having received a diagnosis of thyroid cancer.

For the group of subjects not exposed to radiotherapy and without specific risk factors for DTC:

* None.

Where this trial is running

Bologna and 1 other locations

• UO Medicina Nucleare - IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
• UOC Pediatria - IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Federico Baronio

Conditions Thyroid Carcinoma; Pediatric Cancer