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

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ClinicalTrials.gov Identifier: NCT00420862
Recruitment Status : Terminated
First Posted : January 11, 2007
Last Update Posted : January 11, 2007
Sponsor:
Collaborator:
Lega Italiana per la Lotta contro i Tumori
Information provided by:
Istituto Clinico Humanitas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Spiral Computed Tomography Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : June 2001
Study Completion Date : February 2010

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00420862     History of Changes
Other Study ID Numbers: DANTE
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

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