The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
1 other identifier
interventional
2,400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lung-cancer
Started Jun 2001
Longer than P75 for phase_3 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 10, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJanuary 11, 2007
January 1, 2007
January 10, 2007
January 10, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
Related Publications (1)
Infante M, Lutman FR, Cavuto S, Brambilla G, Chiesa G, Passera E, Angeli E, Chiarenza M, Aranzulla G, Cariboni U, Alloisio M, Incarbone M, Testori A, Destro A, Cappuzzo F, Roncalli M, Santoro A, Ravasi G; DANTE Study Group. Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial. Lung Cancer. 2008 Mar;59(3):355-63. doi: 10.1016/j.lungcan.2007.08.040. Epub 2007 Oct 23.
PMID: 17936405DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gianni Ravasi, MD
Istituto Clinico Humanitas
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2007
First Posted
January 11, 2007
Study Start
June 1, 2001
Study Completion
February 1, 2010
Last Updated
January 11, 2007
Record last verified: 2007-01