Lung CancerNCT06376097
Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service.
An observational study of Lung Cancer, run by AstraZeneca at 1 site in Brazil.
Trial summary
Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Lung Cancer
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Apr 2023to 29 Nov 2026
- 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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the outpatient clinics and wards of the Hospital das Clínicas of the Faculty of Medicine of Botucatu (HCFMB). The estimated sample size is 1000 patients. All patients recruited for this work who are diagnosed with a tobacco-related disease will be referred for outpatient monitoring and treatment of their pathologies. In addition, active smokers who wish to do so will be offered the Smoking Cessation Program.
Who may be able to join
- Age between 45 and 74 years old; Smoker with a smoking history of at least 30 pack-years or former smoker who has quit smoking for less than 15 years; Never having participated in a lung cancer screening program ; Signing of the free and informed consent form.
Who cannot join
- Patients with chronic diseases (cardiovascular, pulmonary, hepatic, renal or metabolic) at an advanced stage that limit life expectancy or make it impossible to perform a curative surgical procedure; Patients being treated for tuberculosis or other granulomatous diseases; Patients diagnosed with previous neoplasm(s) that could develop lung metastases; Pregnant women; Patients who, for some reason, are unable to undergo low-dose chest computed tomography; Patients previously submitted to thoracic radiotherapy.
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
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)
Botucatu, São Paulo, 18618-686
Erica Hasimoto, (14) 99792-0222, ericanh80@hotmail.com
About this study
Official title: Implementation of a Lung Cancer Screening Program in a Public Service, Using Low-dose Tomography and Metabolomics Evaluation
Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service.
Read the detailed description
Patients' clinical data (recruited from the outpatient clinics and wards of Hospital das Clínicas from the Faculty of Medicine of Botucatu) will be collected in a specific form, developed to this work, containing the following data: demographic characteristics (name, age, sex, race, profession, marital status, monthly income and education), main diagnosis and diseases associated, assessment of comorbidities using the Charlson Index, and Hospital Health Scale.
Anxiety and Depression (HAD Scale), use of maintenance medications, history of smoking (active or not, calculation of smoking load), body composition (mass index body- BMI calculation) and pulse oximetry measurement. All patients included will undergo low-dose radiation tomography and spirometry. All patients active smokers, who wish to stop smoking, will be referred to the outpatient clinic smoking cessation. Specific measurements will be applied if there is a diagnosis of COPD by spirometry (the BODE Index questionnaires, Dyspnea Index-Medical Modified Research Council, TC6) and patients will be referred to the outpatient clinic specific COPD for follow-up in the service. Subsequently, the anxiety and depression assessments. The tracking protocol will follow the recommendations of repeat the low-dose radiation chest tomography every year, if normal, until complete two years of follow-up. In this case, the patient will be discharged from the tracking. If the patient presents changes in the tomography, follow-up protocol according to the size of the lesions will be carried out. Morbidity and mortality assessment will be carried out in patients diagnosed with lung cancer.
- Conditions
- Lung Cancer
- Keywords
- Observational; Lung Cancer; Screening;
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute number and frequency of false-negative lung nodules .
Determine the prevalence of pulmonary nodules identified in the target population and the rate of false negative ones. Patients with suspicious nodules will be referred for transthoracic biopsy guided by tomography or a surgical biopsy.
Measured: Dec, 2024
Secondary outcomes (3)
Assess adherence to smoking cessation treatment in active smokers who enter screening.
Adherence to smoking cessation treatment will be objectively measured by the following calculation: number of smokers who stopped smoking after inclusion in the screening project / total number of mokers included. Information on smoking cessation will be extracted from the patient's medical record, from medical appointment carried out by the pulmonology team.
Measured: Dec, 2024
Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic.
The evaluation of morbidity and mortality will be objectively measured by the following calculations:
-Morbidity: number of individuals who underwent an invasive procedure and who had complications / number of individuals who underwent an invasive procedure.
Mortality: number of individuals who underwent an invasive procedure and died due to the procedure or a later compliaction / number of individuals who underwent an invasive procedure.
Examples of complications after such procedures are: pneumonia after bronchoscopy or surgical procedures, pneumothorax and bleeding after bronchoscopy, surgical wound infection after surgical procedures, pneumothorax and hemothorax after transthoracic biopsy and death resulting from any invasive procedure
Measured: Dec, 2024
Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program.
The costs of the screening program will comprise the following: medical consultations and by the multidisciplinary team, spirometry and CT scans. And when necessary, hospitalizations and invasive exams for the etiological investigation of the changes found in CT scans, such as bronchoscopy, transthoracic biopsy or surgical procedure.
All costs from the program and treatment of early-stage diagnosed patients will be compared with a patient seen and treated in advanced stages of lung cancer (historical data). All costs will be estimated using data from hospital records.
Measured: Dec, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start19 Apr 2023
- Primary completion29 Nov 2026 (estimated)
- Study completion29 Nov 2026 (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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erica N Hasimoto, Principal investigator, Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376097
- Sponsor's protocol ID
- D5162R00036
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2024
- Last updated
- 1 Sep 2026
- Results posted
- 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. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Lung Cancer Screening Program in a Public Service, Using Low-dose Tomography and Metabolomics Evaluation
- ClinicalTrials.gov ID
- NCT06376097
- Acronym / sponsor ID
- D5162R00036
- Conditions
- Lung Cancer
- Keywords
- Observational; Lung Cancer; Screening;
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 19 Apr 2024 (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.
Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service.
Detailed description
Patients' clinical data (recruited from the outpatient clinics and wards of Hospital das Clínicas from the Faculty of Medicine of Botucatu) will be collected in a specific form, developed to this work, containing the following data: demographic characteristics (name, age, sex, race, profession, marital status, monthly income and education), main diagnosis and diseases associated, assessment of comorbidities using the Charlson Index, and Hospital Health Scale.
Anxiety and Depression (HAD Scale), use of maintenance medications, history of smoking (active or not, calculation of smoking load), body composition (mass index body- BMI calculation) and pulse oximetry measurement. All patients included will undergo low-dose radiation tomography and spirometry. All patients active smokers, who wish to stop smoking, will be referred to the outpatient clinic smoking cessation. Specific measurements will be applied if there is a diagnosis of COPD by spirometry (the BODE Index questionnaires, Dyspnea Index-Medical Modified Research Council, TC6) and patients will be referred to the outpatient clinic specific COPD for follow-up in the service. Subsequently, the anxiety and depression assessments. The tracking protocol will follow the recommendations of repeat the low-dose radiation chest tomography every year, if normal, until complete two years of follow-up. In this case, the patient will be discharged from the tracking. If the patient presents changes in the tomography, follow-up protocol according to the size of the lesions will be carried out. Morbidity and mortality assessment will be carried out in patients diagnosed with lung cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the outpatient clinics and wards of the Hospital das Clínicas of the Faculty of Medicine of Botucatu (HCFMB). The estimated sample size is 1000 patients. All patients recruited for this work who are diagnosed with a tobacco-related disease will be referred for outpatient monitoring and treatment of their pathologies. In addition, active smokers who wish to do so will be offered the Smoking Cessation Program.
Key inclusion criteria (1 listed)
- Age between 45 and 74 years old; Smoker with a smoking history of at least 30 pack-years or former smoker who has quit smoking for less than 15 years; Never having participated in a lung cancer screening program ; Signing of the free and informed consent form.
Key exclusion criteria (1 listed)
- Patients with chronic diseases (cardiovascular, pulmonary, hepatic, renal or metabolic) at an advanced stage that limit life expectancy or make it impossible to perform a curative surgical procedure; Patients being treated for tuberculosis or other granulomatous diseases; Patients diagnosed with previous neoplasm(s) that could develop lung metastases; Pregnant women; Patients who, for some reason, are unable to undergo low-dose chest computed tomography; Patients previously submitted to thoracic radiotherapy.
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
Absolute number and frequency of false-negative lung nodules .
Time frame: Dec, 2024
Determine the prevalence of pulmonary nodules identified in the target population and the rate of false negative ones. Patients with suspicious nodules will be referred for transthoracic biopsy guided by tomography or a surgical biopsy.
3 secondary outcomes
Assess adherence to smoking cessation treatment in active smokers who enter screening.
Time frame: Dec, 2024
Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic.
Time frame: Dec, 2024
Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program.
Time frame: Dec, 2024
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 1 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. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Related trials for Lung Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
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
Erica N Hasimoto principal investigator
Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 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?
Absolute number and frequency of false-negative lung nodules . (time frame: Dec, 2024). 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 1 Sep 2026.