Status:
TERMINATED
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Lega Italiana per la Lotta contro i Tumori
Conditions:
Lung Cancer
Eligibility:
MALE
60-74 years
Phase:
PHASE3
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
February 1 2010
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT00420862
Start Date
June 1 2001
End Date
February 1 2010
Last Update
January 11 2007
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089