Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy

NCT07473518 | Recruiting

• 1 other identifier: KTir-Ped
• Study Type: observational
• Target: 2,550
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to define the optimal surveillance strategy for children exposed to radiotherapy by assessing the incidence, risk factors, and timing of thyroid nodules and differentiated thyroid cancer. It also investigates the genetic features of thyroid tumors in this population to identify predictive biomarkers of onset, malignancy, and aggressiveness. Ultimately, the goal is to support more personalized management, including tailored surgery and targeted therapies.

Conditions

Thyroid Carcinoma; Pediatric Cancer

Outcome Measures

Primary Outcomes (2)

• To calculate the incidence of thyroid nodules and/or thyroid cancer in patients who were exposed and not exposed to radiotherapy

  Presence of thyroid nodules and/or thyroid cancer (yes/no)

  At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group

• "To identify risk factors for the development of thyroid nodules and/or thyroid cancer in patients who underwent radiotherapy during childhood

  Presence of thyroid nodules and/or thyroid cancer (yes/no)

  At 4 years after radiotherapy

Secondary Outcomes (1)

• To identify genetic biomarkers predictive of thyroid cancer development in the pediatric population, both exposed and not exposed to radiotherapy

  At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group

Eligibility Criteria

• Age: 10 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Oncologic patients who underwent radiotherapy during childhood between January 1, 1999, and December 31, 2018, with a follow-up of at least 4 years at the Pediatric Unit of IRCCS AOU Bologna. * Subjects not exposed to radiotherapy and without specific risk factors for differentiated thyroid cancer (DTC), who had a thyroid ultrasound performed during childhood at the Nuclear Medicine Unit of IRCCS AOU Bologna between January 1, 1999, and December 31, 2018.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

UO Medicina Nucleare - IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

UOC Pediatria - IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Federico Baronio

CONTACT

00390512144816; federico.baronio@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: July 30, 2025
• Primary Completion: July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-12

Locations

IT (2)