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临床试验/NCT07255482
NCT07255482已完成不适用

Mortality Benefit of Ultrasound for Incidental Thyroid Nodules Identified With PET Imaging: A Non-Inferiority Emulated Target Trial

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 874 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
874
试验地点
1
主要终点
All-Cause Mortality

研究概览

简要总结

The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.

详细描述

Study Hypothesis: The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound within 3 months is no worse than 5% lower than those who did have ultrasound.

Outcome Measures:

Primary Outcome: All-cause mortality. Secondary Outcomes: Numbers of thyroid cancer diagnoses, thyroid ultrasounds, thyroid biopsies, and thyroid surgeries Exploratory Outcomes: Types of thyroid cancer diagnoses

Study Population: All patients age 18-years and older with incidental thyroid nodule on PET-CT performed between 1/1/2015 and 12/31/2021.

Sites/Facilities: Mass General Brigham healthcare system including Massachusetts General Hospital, Brigham and Women's Hospital, Mass Eye and Ear, and associated community sites.

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

入选标准

  • •Thyroid nodule on PET-CT performed 1/1/2015 to 12/31/2021
  • •At least one clinical note in the EHR from the 36-month window prior to the PET

排除标准

  • •Thyroid ultrasound listed in the medical record in the prior 3 years
  • •Documented history of prior thyroid cancer diagnosis

研究组 & 干预措施

Patients with thyroid nodule on PET

干预措施: Thyroid Ultrasound (Diagnostic Test)

结局指标

主要结局

All-Cause Mortality

时间窗: 7 Years

次要结局

  • Number of Thyroid Cancer Diagnoses(7 Years)
  • Number of Thyroid Ultrasound Examinations(7 Years)
  • Number of Thyroid Biopsies(7 Years)
  • Number of Thyroid Surgeries(7 Years)

研究者

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

Jeffrey P Guenette

Associate Professor of Radiology

Brigham and Women's Hospital

研究点 (1)

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