search
Back to results

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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Spiral Computed Tomography
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Lung neoplasms, Early diagnosis, Screening, Spiral Computed Tomography, Randomized Controlled Trial

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Istituto Clinico Humanitas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 10, 2007
Last Updated
January 10, 2007
Sponsor
Istituto Clinico Humanitas
Collaborators
Lega Italiana per la Lotta contro i Tumori
search

1. Study Identification

Unique Protocol Identification Number
NCT00420862
Brief Title
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Istituto Clinico Humanitas
Collaborators
Lega Italiana per la Lotta contro i Tumori

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung neoplasms, Early diagnosis, Screening, Spiral Computed Tomography, Randomized Controlled Trial

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Spiral Computed Tomography

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianni Ravasi, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17936405
Citation
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. doi: 10.1016/j.lungcan.2007.08.040. Epub 2007 Oct 23.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs