跳至主要内容
临床试验/NCT07473518
NCT07473518招募中不适用

Thyroid Carcinoma in Cancer Patients Undergoing Radiotherapy

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 2,550 人开始时间: 2025年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,550
试验地点
2
主要终点
To calculate the incidence of thyroid nodules and/or thyroid cancer in patients who were exposed and not exposed to radiotherapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
10 Years 至 43 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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:

结局指标

主要结局

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

时间窗: 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

时间窗: At 4 years after radiotherapy

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Baronio

MD

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (2)

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