Lung CancerLUSIPNCT07279948
Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP)
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Brazil.
Trial summary
A prospective, longitudinal, single-arm interventional study of lung cancer screening. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer
- How many people
- 477 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Oct 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study will be adult patients, both sexes, a high-risk smoker selected from a population with a high prevalence of granulomatous disease. The smokers at high risk for developing lung cancer, in a population with a high prevalence of granulomatous disease made up of SUS users registered in the Smoking Cessation Program in the Municipality of Rio de Janeiro, Brazil.
Who may be able to join
- In order, to be eligible for the study, patients must fulfill all the following inclusion criteria:
- Age between ≥50 and ≤80 years.
- Be a current smoker or have quit 15 years ago or less.
- Have participated or are currently participating in smoking cessation program.
- Lifetime smoking exposure equal to or greater than 20 pack-year.
- Provided signed informed consent (ICF)
Who cannot join
- In order, to be exclude for the study, patients must at least one of the following exclusion criteria:
- Contraindications to the screening examination: (claustrophobic or weighing more than 130 kgs).
- Inability to climb 3 stair steps non-stop (36 steps).
- Disabling dyspnea
- Symptomatic (with signs and symptoms suspicious of breast cancer lung, namely):
- pleuritic chest pain
Show all 17Show fewer
- rapidly progressive dyspnea of recent onset
- hemoptysis
- unexplained hoarseness, lasting more than 1 month.
- bone pain
- supraclavicular lymphadenopathy or cervical lymphadenopathy persistent
- unexplained weight loss of 5% or more of weight in less than 6 months
- Previous history of malignant neoplasm (excluding non-melanoma skin cancer) diagnosed less than 10 years before the date of the interview;
- Patients with diagnostic of severe psychiatric disease
- Immunosuppressed by illness or drugs.
- Subjected to anterior lung resection even when determined due to an etiology other than malignant neoplasia.
- Person with a serious terminal illness that contraindicates curative lung surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
A prospective, longitudinal, single-arm interventional study of lung cancer screening.
Read the detailed description
Main hypothesis: The tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease could leads to an increase in the proportion of false-positive cases resulting in unnecessary medical procedures, which represents a waste of resources and a risk for patients.
Main objective: To assess whether the percentage of false-positive cases with indication of biopsy after lung cancer screening with low-dose CT in high-risk smokers in a population with a high prevalence of granulomatous disease will be within the expected range according to other studies in the literature.
As there is robust evidence of the effectiveness of screening in reducing mortality from lung cancer, we expect the project to bring benefits to patients treated for image-detected lung cancer in the project, with reduced staging and a shorter time between diagnosis and treatment. Therefore , although the focus is on the safety of screening, the project will also monitor the cancer detection rate, which is a surrogate endpoint of effectiveness.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
• Proportion of negative cases on screening according to the Lung-RADS classification.
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
Measured: Last 10 years
• Proportion of false-positives.
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
Measured: Last 10 years
Secondary outcomes (7)
• Cancer detection rate.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: last 10 years
• Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: Last 10 years
• Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator).
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: Last 10 years
• Percentage of adherence to follow-up.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: Last 10 years
• Prevalence of granulomatous disease in screening positive cases
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: Last 10 years
• Prevalence of incidental findings.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: Last 10 years
• Prevalence of clinically relevant incidental findings that required follow-up.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Measured: Last 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start30 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 477 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arn Migowski Rocha dos Santos, Principal investigator, Instituto Nacional de Câncer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279948
- Sponsor's protocol ID
- D133FR00225
- Acronym
- LUSIP
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP)
- ClinicalTrials.gov ID
- NCT07279948
- Acronym / sponsor ID
- LUSIP / D133FR00225
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 477 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Dec 2025 (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.
A prospective, longitudinal, single-arm interventional study of lung cancer screening.
Detailed description
Main hypothesis: The tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease could leads to an increase in the proportion of false-positive cases resulting in unnecessary medical procedures, which represents a waste of resources and a risk for patients.
Main objective: To assess whether the percentage of false-positive cases with indication of biopsy after lung cancer screening with low-dose CT in high-risk smokers in a population with a high prevalence of granulomatous disease will be within the expected range according to other studies in the literature.
As there is robust evidence of the effectiveness of screening in reducing mortality from lung cancer, we expect the project to bring benefits to patients treated for image-detected lung cancer in the project, with reduced staging and a shorter time between diagnosis and treatment. Therefore , although the focus is on the safety of screening, the project will also monitor the cancer detection rate, which is a surrogate endpoint of effectiveness.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will be adult patients, both sexes, a high-risk smoker selected from a population with a high prevalence of granulomatous disease. The smokers at high risk for developing lung cancer, in a population with a high prevalence of granulomatous disease made up of SUS users registered in the Smoking Cessation Program in the Municipality of Rio de Janeiro, Brazil.
Key inclusion criteria (6 listed)
- In order, to be eligible for the study, patients must fulfill all the following inclusion criteria:
- Age between ≥50 and ≤80 years.
- Be a current smoker or have quit 15 years ago or less.
- Have participated or are currently participating in smoking cessation program.
- Lifetime smoking exposure equal to or greater than 20 pack-year.
Key exclusion criteria (17 listed)
- In order, to be exclude for the study, patients must at least one of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Proportion of negative cases on screening according to the Lung-RADS classification.
Time frame: Last 10 years
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
• Proportion of false-positives.
Time frame: Last 10 years
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
7 secondary outcomes
• Cancer detection rate.
Time frame: last 10 years
• Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)
Time frame: Last 10 years
• Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator).
Time frame: Last 10 years
• Percentage of adherence to follow-up.
Time frame: Last 10 years
• Prevalence of granulomatous disease in screening positive cases
Time frame: Last 10 years
• Prevalence of incidental findings.
Time frame: Last 10 years
• Prevalence of clinically relevant incidental findings that required follow-up.
Time frame: Last 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
AstraZeneca Clinical Study Information Center contact
Arn Migowski Rocha dos Santos principal investigator
Instituto Nacional de Câncer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Brazil.
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 6 inclusion and 17 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Proportion of negative cases on screening according to the Lung-RADS classification. (time frame: Last 10 years). The study lists 2 primary outcomes in all. 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 11 Sep 2026.