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

This study has been terminated.

First Received: January 10, 2007 No Changes Posted

Sponsors and Collaborators:	Istituto Clinico Humanitas Lega Italiana per la Lotta contro i Tumori
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00420862

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Procedure: Spiral Computed Tomography	Phase III

MedlinePlus related topics: CT Scans Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Open Label, Uncontrolled, Parallel Assignment

Further study details as provided by Istituto Clinico Humanitas:

Estimated Enrollment:	2400
Study Start Date:	June 2001
Estimated Study Completion Date:	February 2010

Eligibility

Ages Eligible for Study:	60 Years to 74 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420862

Locations

Italy, MI
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Lega Italiana per la Lotta contro i Tumori

Investigators

Principal Investigator:

Gianni Ravasi, MD

Istituto Clinico Humanitas

More Information

No publications provided by Istituto Clinico Humanitas

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	DANTE
Study First Received:	January 10, 2007
Last Updated:	January 10, 2007
ClinicalTrials.gov Identifier:	NCT00420862 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:

Lung neoplasms
Early diagnosis
Screening
Spiral Computed Tomography
Randomized Controlled Trial

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009