A prospective, longitudinal, single-arm interventional study of lung cancer screening.

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.

Inclusion Criteria:

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)

Exclusion Criteria:

• 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
    • 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.

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.

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.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.