Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
A prospective, longitudinal, single-arm interventional study of lung cancer screening.
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.
Primary outcome measures
- • Proportion of negative cases on screening according to the Lung-RADS classification. [Time frame: Last 10 years]
- • Proportion of false-positives. [Time frame: Last 10 years]
Secondary outcome measures (7)
- • Cancer detection rate. [Time frame: last 10 years]
- • Willingness to be screened (ie, proportion of eligible patients actually signing up for the study) [Time frame: 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). [Time frame: Last 10 years]
- • Percentage of adherence to follow-up. [Time frame: Last 10 years]
- • Prevalence of granulomatous disease in screening positive cases [Time frame: Last 10 years]
- • Prevalence of incidental findings. [Time frame: Last 10 years]
- • Prevalence of clinically relevant incidental findings that required follow-up. [Time frame: Last 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Brazil · 1 center
- Research Site — Rio de Janeiro
Identifiers
NCT: NCT07279948 · D133FR00225