Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP) (LUSIP)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 477

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20230-130
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Proportion of negative cases on screening according to the Lung-RADS classification.	Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.	Last 10 years
• Proportion of false-positives.	Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.	Last 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Cancer detection rate.	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	last 10 years
• Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years
• Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator).	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years
• Percentage of adherence to follow-up.	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years
• Prevalence of granulomatous disease in screening positive cases	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years
• Prevalence of incidental findings.	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years
• Prevalence of clinically relevant incidental findings that required follow-up.	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years
• Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator).	Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.	Last 10 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Arn Migowski Rocha dos Santos, Instituto Nacional de Cancer

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: D133FR00225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No