Thyroid CarcinomaNCT07473518
Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy
An observational study of Thyroid Carcinoma and Pediatric Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 43 years
- Conditions the study is for
- Thyroid Carcinoma, Pediatric Cancer
- How many people
- 2,550 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Jul 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 43 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
UO Medicina Nucleare - IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Letizia Calderoni, 00390512144816, letizia.calderoni4@unibo.it
- Recruiting
UOC Pediatria - IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Federico Baronio, 00390512144816, federico.baronio@aosp.bo.it
About this study
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.
Read the 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.
- Conditions
- Thyroid Carcinoma, Pediatric Cancer
- Medical subject headings
- Thyroid Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Presence of thyroid cancer (yes/no)
Measured: At 4 years after radiotherapy for the radiotherapy-exposed group; At the time of ultrasound for the non-radiotherapy group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start30 Jul 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,550 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Baronio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473518
- Sponsor's protocol ID
- KTir-Ped
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT07473518
- Acronym / sponsor ID
- KTir-Ped
- Conditions
- Thyroid Carcinoma, Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,550 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
"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)
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Carcinoma and Pediatric Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Baronio (00390512144816, federico.baronio@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.