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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420862
• Other study ID #: DANTE
• Status: Terminated
• Phase: Phase 3
• First received: January 10, 2007
• Last updated: January 10, 2007
• Start date: June 2001
• Est. completion date: February 2010

Study information

• Verified date: January 2007
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2400
• Est. completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 74 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Spiral Computed Tomography

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Lega Italiana per la Lotta contro i Tumori

Country where clinical trial is conducted

Italy,