跳至主要内容
临床试验/NCT04366661
NCT04366661Unknown不适用

Iraqi Trial for Lung Cancer Screening

Oncology Teaching Hospital, Baghdad1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
The efficacy of LD CT in lung cancer screening

研究概览

简要总结

Lung cancer is a global problem. Worldwide, 1.2 million people die of lung cancer each year. In Iraq, lung cancer is the most common malignancy after breast cancer and the leading cause of cancer-related death. Tobacco smoking plays a major role in lung cancer; it is reported in 85-90% of lung cancer patients yet environmental tobacco smoke, environmental and domestic air pollution, work-related risk factors, radon exposure, and viruses may also have an impact on lung cancer incidence rates. Early detection of the disease before patients develop symptoms considers the best way to improve patient outcomes. IT LUCAS is designed to evaluate the utility of low-dose computed tomography (LDCT) screening in early detection and management of lung cancer in high-risk people.

详细描述

Background Lung cancer is a global problem. Worldwide, 1.2 million people die of lung cancer each year. In Iraq, lung cancer is the most common malignancy after breast cancer and the leading cause of cancer-related death. Tobacco smoking plays a major role in lung cancer; it is reported in 85-90% of lung cancer patients yet environmental tobacco smoke, environmental and domestic air pollution, work-related risk factors, radon exposure, and viruses may also have an impact on lung cancer incidence rates. Early detection of the disease before patients develop symptoms considers the best way to improve patient outcomes. Screening for lung cancer using low dose computed tomography (LDCT) has been the subject of research studies since the 1990s. It has been reported to be superior to CXR and septum cytology for small tumors detection.

Aim of the study IT LUCAS is designed to evaluate the utility of LDCT screening in early detection and management of lung cancer in high-risk people in Iraq.

Study design 500 healthy participants aged 50-75 years with a history of smoking of at least 30 pack year of smoking were recruited from Ministries of Oil and Transport. They were offered Low dose CT of the chest. Nodules with suspicious (Lung RADs 4A or 4B) findings were classified as positive and referred to the Respiratory Department for further workup and biopsy. Nodules with Lung RADS 3 features are reviewed after 6 months while those with Lung RADS 2 offered a LDCT after 12 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female
  • aged between 50 and 75
  • smokers or ex-smoker
  • tobacco exposure of more than 30 pack-years

排除标准

  • History of cancer within the last 5 years other than non-melanoma skin cancer or carcinoma in situ,
  • heart or respiratory severe co-morbidity with contraindications to thoracoscopy

结局指标

主要结局

The efficacy of LD CT in lung cancer screening

时间窗: 2 years

The number of lung nodules with Lung RADS 4A, 4B and 4X, cancer predictive value and false-positive value

次要结局

  • noncancerous lung lesions(2 years)

研究者

发起方
Oncology Teaching Hospital, Baghdad
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Iraqi Trial for Lung Cancer Screening | 临床试验