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

Phase 3

Terminated

• Conditions: Lung Cancer

• Registration Number: NCT00420862
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Status Verified: 2007-01
• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Last Update Submitted: 2007-01-10
• Study First Posted: 2007-01-11
• Last Update Posted: 2007-01-11
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy