NCT07473518

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,550

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jul 2025Jul 2027

Study Start

First participant enrolled

July 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Expected
Last Updated

March 16, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Thyroid CarcinomaPediatric 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

Age10 Years - 43 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Federico Baronio

CONTACT

00390512144816federico.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)