Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy

March 11, 2026 updated by: Federico Baronio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study aims to improve our understanding of how best to monitor children who have been exposed to radiotherapy, a group known to be at higher risk of developing thyroid nodules and differentiated thyroid cancer (DTC). Current pediatric guidelines are not fully consistent in defining the most appropriate surveillance strategy for these patients. By implementing an early and intensive clinical and ultrasound follow-up, the study seeks to provide clearer evidence on how frequently thyroid abnormalities occur, which factors increase the risk, and when these conditions typically arise after radiotherapy. The ultimate goal is to define a surveillance approach that enables early detection while remaining practical, cost-effective, and mindful of the emotional burden placed on young oncology patients.

Another important focus of the study is the genetic characterization of thyroid tumors in children exposed to radiotherapy. Evidence supporting the use of molecular testing in the diagnostic and therapeutic management of pediatric thyroid cancer is still limited. By analyzing genetic biomarkers in both cytological and histological samples, the study aims to explore their role in predicting the development, malignancy, and aggressiveness of thyroid tumors. These findings could help pave the way toward more personalized care, supporting more conservative surgical approaches when appropriate and facilitating the use of targeted therapies.

Study Type

Observational

Enrollment (Estimated)

2550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • UO Medicina Nucleare - IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
      • Bologna, Italy, 40138
        • Recruiting
        • UOC Pediatria - IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To calculate the incidence of thyroid nodules and/or thyroid cancer in patients who were exposed and not exposed to radiotherapy
Time Frame: At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group
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
Time Frame: At 4 years after radiotherapy
Presence of thyroid nodules and/or thyroid cancer (yes/no)
At 4 years after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify genetic biomarkers predictive of thyroid cancer development in the pediatric population, both exposed and not exposed to radiotherapy
Time Frame: At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group
Presence of thyroid cancer (yes/no)
At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTir-Ped

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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