Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP)
ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorAstraZeneca
About this trial
A prospective, longitudinal, single-arm interventional study of lung cancer screening.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Contraindications to the screening examination: (claustrophobic or weighing more than 130 kgs).
Inability to climb 3 stair steps non-stop (36 steps).
Disabling dyspnea
pleuritic chest pain
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
• 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.
Time frame
Last 10 years2
• 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.
Time frame
Last 10 yearsSecondary outcomes
1
• Cancer detection rate.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame
last 10 years2
• 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.
Time frame
Last 10 years3
• 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.
Time frame
Last 10 years4
• 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.
Time frame
Last 10 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: