Lung CancerITLUCASNCT04366661
Iraqi Trial for Lung Cancer Screening
A study testing low dose CT in people with Lung Cancer, run by Oncology Teaching Hospital, Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- low dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2018to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female
- aged between 50 and 75
- smokers or ex-smoker
- tobacco exposure of more than 30 pack-years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- low dose CT
- Keywords
- smoking, envirumental polution
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose CTDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| screening | Experimental | Participants undergo low dose CT of the chest Receives: Diagnostic Test: low dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
noncancerous lung lesions
the number of nodules with Lung RADS 2 and 3 features
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jun 2018
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Teaching Hospital, Baghdad
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Enam A Khalil, Principal investigator, Oncology Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366661
- Sponsor's protocol ID
- OTH267
- Acronym
- ITLUCAS
- Status last verified
- Mar 2021
- First submitted
- 22 Apr 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iraqi Trial for Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT04366661
- Acronym / sponsor ID
- ITLUCAS / OTH267
- Conditions
- Lung Cancer
- Keywords
- smoking, envirumental polution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oncology Teaching Hospital, BaghdadOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening | Experimental | Diagnostic Test: low dose CTParticipants undergo low dose CT of the chest |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female
- aged between 50 and 75
- smokers or ex-smoker
- tobacco exposure of more than 30 pack-years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose CTInvited 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 | Diagnostic test | screening |
Primary outcome
The efficacy of LD CT in lung cancer screening
Time frame: 2 years
The number of lung nodules with Lung RADS 4A, 4B and 4X, cancer predictive value and false-positive value
1 secondary outcome
noncancerous lung lesions
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Iraqi Cancer RigistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enam A Khalil principal investigator
Oncology Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose CT in people with Lung Cancer, run by Oncology Teaching Hospital, Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of LD CT in lung cancer screening (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.