The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography

Istituto Clinico Humanitas

Status and phase

Terminated

Phase 3

Conditions

Lung Cancer

Treatments

Procedure: Spiral Computed Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT00420862

DANTE

Details and patient eligibility

About

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.

Sex

Male

Ages

60 to 74 years old

Volunteers

Accepts Healthy Volunteers

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