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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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:

U.S. FDA Resources

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
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 ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Istituto Clinico Humanitas:
Lung neoplasms
Early diagnosis
Screening
Spiral Computed Tomography
Randomized Controlled Trial

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013