临床试验/NCT05428371

NCT05428371尚未招募不适用

A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules

University of Cagliari1 个研究点分布在 1 个国家目标入组 256 人开始时间: 2023年1月1日最近更新: 2022年6月23日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: University of Cagliari
入组人数: 256
试验地点: 1
主要终点: Identification of biomarkers of thyroid carcinoma

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)

排除标准

•Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
•Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
•Patients with distant metastases

结局指标

主要结局

Identification of biomarkers of thyroid carcinoma

时间窗: 50 months

Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma

次要结局

Elaboration of diagnostic algorithm(60 months)

研究者

发起方

University of Cagliari

申办方类型

Other

责任方

Principal Investigator

主要研究者

Fabio Medas

Associate Professor

University of Cagliari

研究点 (1)

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