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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014