Clinical trial NCT04366661: Iraqi Trial for Lung Cancer Screening
Official title: Iraqi Trial for Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: smoking
envirumental polution
Lead sponsor: Oncology Teaching Hospital, Baghdad
Sponsor class: OTHER_GOV
First posted: 2020-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The efficacy of LD CT in lung cancer screening
timeFrame: 2 years
Secondary outcomes:
measure: noncancerous lung lesions
timeFrame: 2 years
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Oncology Teaching Hospital
Study officials:
affiliation: Oncology Teaching Hospital
name: Enam A Khalil
role: PRINCIPAL_INVESTIGATOR
References: