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

NCT06376097 | Recruiting

• 1 other identifier: D5162R00036
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

Observational; Lung Cancer; Screening;

Outcome Measures

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.

  Dec, 2024

Secondary Outcomes (3)

• Assess adherence to smoking cessation treatment in active smokers who enter screening.

  Dec, 2024

• Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic.

  Dec, 2024

• Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program.

  Dec, 2024

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age between 45 and 74 years old; Smoker with a smoking history of at least 30 pack-years or former smoker who has quit smoking for less than 15 years; Never having participated in a lung cancer screening program ; Signing of the free and informed consent form.

You may not qualify if:

• Patients with chronic diseases (cardiovascular, pulmonary, hepatic, renal or metabolic) at an advanced stage that limit life expectancy or make it impossible to perform a curative surgical procedure; Patients being treated for tuberculosis or other granulomatous diseases; Patients diagnosed with previous neoplasm(s) that could develop lung metastases; Pregnant women; Patients who, for some reason, are unable to undergo low-dose chest computed tomography; Patients previously submitted to thoracic radiotherapy.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)

Botucatu, São Paulo, 18618-686, Brazil

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Erica N Hasimoto

  Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)

  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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: April 19, 2023
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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)