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

This study has been terminated.
Sponsor:
Collaborator:
Lega Italiana per la Lotta contro i Tumori
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00420862
First received: January 10, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 10, 2007
January 10, 2007
June 2001
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No Changes Posted
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The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
Not Provided

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Lung Cancer
Procedure: Spiral Computed Tomography
Not Provided
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. Epub 2007 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2400
February 2010
Not Provided

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
Male
60 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00420862
DANTE
Not Provided
Not Provided
Istituto Clinico Humanitas
Lega Italiana per la Lotta contro i Tumori
Principal Investigator: Gianni Ravasi, MD Istituto Clinico Humanitas
Istituto Clinico Humanitas
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP