Lung cancer screening program for smokers using low-dose tomography and metabolomic evaluation.
Implementation of a Lung Cancer Screening Program in a Public Service, Using Low-dose Tomography and Metabolomics Evaluation
This study is testing a lung cancer screening program for smokers to see if using low-dose scans and health evaluations can help catch cancer early and improve their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 45 Years to 74 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Botucatu, São Paulo) |
| Trial ID | NCT06376097 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the implementation of a lung cancer screening program targeting smokers within a public health service. It involves collecting comprehensive clinical data from patients, including demographic information, smoking history, and assessments of comorbidities. Participants will undergo low-dose radiation tomography and spirometry, with follow-up screenings conducted annually for two years if initial results are normal. The program also includes referrals for smoking cessation and management of chronic obstructive pulmonary disease (COPD) if diagnosed.
Who should consider this trial
Good fit: Ideal candidates are smokers aged 45 to 74 with a significant smoking history or former smokers who have quit within the last 15 years.
Not a fit: Patients with advanced chronic diseases, previous neoplasms, or those unable to undergo the required imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to earlier detection of lung cancer in high-risk populations, improving patient outcomes.
How similar studies have performed: Other studies have shown success with similar lung cancer screening approaches, indicating potential for effective early detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Where this trial is running
Botucatu, São Paulo
- Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB) — Botucatu, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Erica N Hasimoto — Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB)
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.