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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Procedure: Spiral Computed Tomography | Phase 3 |
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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Ages Eligible for Study: | 60 Years to 74 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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
Italy | |
Istituto Clinico Humanitas | |
Rozzano, MI, Italy, 20089 |
Principal Investigator: | Gianni Ravasi, MD | Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT00420862 |
Other Study ID Numbers: |
DANTE |
First Posted: | January 11, 2007 Key Record Dates |
Last Update Posted: | January 11, 2007 |
Last Verified: | January 2007 |
Lung neoplasms Early diagnosis Screening Spiral Computed Tomography Randomized Controlled Trial |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |