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

NCT07279948 | Not Yet Recruiting

• 1 other identifier: D133FR00225
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• • 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 Outcomes (7)

• • Cancer detection rate.

  last 10 years

• • Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)

  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).

  Last 10 years

• • Percentage of adherence to follow-up.

  Last 10 years

• • Prevalence of granulomatous disease in screening positive cases

  Last 10 years

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Rio de Janeiro, 20230-130, Brazil

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Arn Migowski Rocha dos Santos

  Instituto Nacional de Câncer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: June 30, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

BR (1)