A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort of Patients With Lung Cancer. (LUSIP)

AstraZeneca

Status: Begins enrollment this month

Conditions: Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07279948

D133FR00225

Details and patient eligibility

About

A single-arm observational study to characterize the demographic, clinical features and outcomes of a Brazilian cohort of patients with lung cancer.

Full 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.

Enrollment: 477 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.