Lung Cancer
Conditions
Keywords
Lung neoplasms, Early diagnosis, Screening, Spiral Computed Tomography, Randomized Controlled Trial
Brief summary
High survival rates have been reported for screen-detected Stage I lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective randomized controlled trial exploring the effects of screening with LDCT on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. The prevalence of a set of biomarkers in sputum and blood samples is also being determined.
Interventions
PROCEDURESpiral Computed Tomography
Sponsors
Lega Italiana per la Lotta contro i Tumori
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
60 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Male sex * Age 60-74 years * smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years)
Exclusion criteria
* severe cardiopathy * advanced BPCO with chronic hypoxaemia (rest SatO2 \< 94%) * chronic severe renal insufficiency * hypertension not controlled with drugs * type 2 diabetes or other severe systemic disease * severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient). * severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker * Dementia, psychosis, severe depression or maniac-depressive syndrome * actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, N0, recovered from more than 10 years or other tumors recovered from more than 10 years * transplantation less than 5 years or with rejection episodes in the last 2 years * unable subjects
Countries
Italy
Outcome results
None listed