Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 6:22 AM
Study NCT ID:
NCT04366661
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iraqi Trial for Lung Cancer Screening
Sponsor:
Oncology Teaching Hospital, Baghdad
Organization:
Study Overview
Official Title:
Iraqi Trial for Lung Cancer Screening
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITLUCAS
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: