Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service.
Implementation of a Lung Cancer Screening Program in a Public Service, Using Low-dose Tomography and Metabolomics Evaluation
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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São Paulo
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Botucatu, São Paulo, Brazil, 18618-686
- Recruiting
- Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)
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Contact:
- Erica Hasimoto
- Phone Number: (14) 99792-0222
- Email: ericanh80@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria :
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Absolute number and frequency of false-negative lung nodules .
Time Frame: Dec, 2024
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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.
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Dec, 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess adherence to smoking cessation treatment in active smokers who enter screening.
Time Frame: Dec, 2024
|
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.
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Dec, 2024
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Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic.
Time Frame: Dec, 2024
|
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 |
Dec, 2024
|
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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
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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. |
Dec, 2024
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erica N Hasimoto, Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5162R00036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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