Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-43
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
None.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group2
"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)
Time frame
At 4 years after radiotherapySecondary outcomes
1
To identify genetic biomarkers predictive of thyroid cancer development in the pediatric population, both exposed and not exposed to radiotherapy
Presence of thyroid cancer (yes/no)
Time frame
At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy groupSponsors and contacts
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Source ClinicalTrials.gov