Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service.

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-74
SponsorAstraZeneca

About this trial

Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Dec, 2024

Secondary outcomes

1

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.

Time frame
Dec, 2024
2

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

Time frame
Dec, 2024
3

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.

Time frame
Dec, 2024

Other outcomes

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