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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:
Istituto Clinico Humanitas
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
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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:
Eligibility| Ages Eligible for Study: | 60 Years to 74 Years (Adult, Senior) |
| 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 Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420862
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
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 |
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 July 25, 2017