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临床试验/NCT03922828
NCT03922828已完成不适用

Lung Nodule Prospective Database

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Histology

研究概览

简要总结

Lung cancer is one of the most common cancers in the Singapore population, being the 2nd most commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer amongst females. Pulmonologists, oncologists and thoracic surgeons are often consulted for the evaluation of imaging-identified pulmonary nodules. These may have been identified either incidentally or through screening. The majority of these are indeterminate and definitive investigation with biopsy or resection is invasive and not without risk. Hence, current consensus guidelines adopt a largely expectant strategy in the management of these indeterminate pulmonary nodules.

There is substantial evidence that lung cancer in Asians may be unique with multiple driver mutations, lower age of presentation and may be independent of tobacco exposure. In addition, there are guidelines that recommend that the management of lung nodules in Asia should account for these differences. However, the evidence for alternative recommendations is lacking.

The aim of the study will be to identify radiological and clinical predictors that can improve the diagnosis of lung nodules. These predictors may help build a model for lung nodule evaluation and surveillance.

Prospective database of subjects meeting all of the following inclusion criteria to participate in this study.

  1. Evidence of lung nodule on chest radiograph or Computed Tomography regardless of underlying aetiology
  2. Age ³ 21 years old
  3. Ability to provide informed consent This study will collect existing or prospective data that is part of standard clinical care from the electronic medical record of patients (ambulatory and inpatient from May 2018-2023.

详细描述

  1. BACKGROUND AND RATIONALE

Lung cancer is one of the most common cancers in the Singapore population, being the 2nd most commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer amongst females. Pulmonologists, oncologists and thoracic surgeons are often consulted for the evaluation of imaging-identified pulmonary nodules. These may have been identified either incidentally or through screening. The majority of these are indeterminate and definitive investigation with biopsy or resection is invasive and not without risk. Hence, current consensus guidelines adopt a largely expectant strategy in the management of these indeterminate pulmonary nodules.

There is substantial evidence that lung cancer in Asians may be unique with multiple driver mutations, lower age of presentation and may be independent of tobacco exposure. In addition, there are guidelines that recommend that the management of lung nodules in Asia should account for these differences. However, the evidence for alternative recommendations is lacking. 2. HYPOTHESIS AND OBJECTIVES

The aim of the study will be to identify radiological and clinical predictors that can improve the diagnosis of lung nodules. These predictors may help build a model for lung nodule evaluation and surveillance. 3. EXPECTED RISKS AND BENEFITS

There are likely to be no benefits to subjects. They will not be subject to any novel therapy and their clinical/radiological data will only be collected.

研究设计

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

入排标准

年龄范围
21 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subject must meet all of the following inclusion criteria to participate in this study.
  • Evidence of lung nodule on chest radiograph or Computed Tomography regardless of underlying aetiology
  • Age > 21 years old
  • Ability to provide informed consent

排除标准

  • Subjects who no radiographic evidence of lung nodules or who are unwilling/unable to provide informed consent

结局指标

主要结局

Histology

时间窗: 3 years

Malignant or benign

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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