Iraqi Trial for Lung Cancer Screening (ITLUCAS)
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
low dose CT
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring smoking, envirumental polution
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
Sites / Locations
- Oncology Teaching Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
screening
Arm Description
Participants undergo low dose CT of the chest
Outcomes
Primary Outcome Measures
The efficacy of LD CT in lung cancer screening
The number of lung nodules with Lung RADS 4A, 4B and 4X, cancer predictive value and false-positive value
Secondary Outcome Measures
noncancerous lung lesions
the number of nodules with Lung RADS 2 and 3 features
Full Information
NCT ID
NCT04366661
First Posted
April 22, 2020
Last Updated
March 4, 2021
Sponsor
Oncology Teaching Hospital, Baghdad
1. Study Identification
Unique Protocol Identification Number
NCT04366661
Brief Title
Iraqi Trial for Lung Cancer Screening
Acronym
ITLUCAS
Official Title
Iraqi Trial for Lung Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oncology Teaching Hospital, Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
smoking, envirumental polution
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
screening
Arm Type
Experimental
Arm Description
Participants undergo low dose CT of the chest
Intervention Type
Diagnostic Test
Intervention Name(s)
low dose CT
Intervention Description
Invited participants from institutes exposed to a high level of smoke pollution such as employees of Transport and Oil Ministries are inquired for their personal history of cigarette smoking then subjected to low dose CT
Primary Outcome Measure Information:
Title
The efficacy of LD CT in lung cancer screening
Description
The number of lung nodules with Lung RADS 4A, 4B and 4X, cancer predictive value and false-positive value
Time Frame
2 years
Secondary Outcome Measure Information:
Title
noncancerous lung lesions
Description
the number of nodules with Lung RADS 2 and 3 features
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enam A Khalil
Organizational Affiliation
Oncology Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Teaching Hospital
City
Baghdad
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://moh.gov.iq/upload/upfile/ar/882.pdf
Description
Iraqi Cancer Rigistry
Learn more about this trial
Iraqi Trial for Lung Cancer Screening
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