Lung CancerPhase 3NCT00420862
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
A Phase 3 study testing Spiral Computed Tomography in people with Lung Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 74 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Spiral Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 2,400 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2001to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer
- Being tested
- Spiral Computed Tomography
- Keywords
- Lung neoplasms, Early diagnosis, Screening, Spiral Computed Tomography, Randomized Controlled Trial
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiral Computed TomographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJun 2001
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Lega Italiana per la Lotta contro i Tumori
- Investigators
- Gianni Ravasi, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420862
- Sponsor's protocol ID
- DANTE
- Status last verified
- Jan 2007
- First submitted
- 10 Jan 2007
- Last updated
- 11 Jan 2007
- Results posted
- No
Publications
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.
PubMed 17936405
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
- ClinicalTrials.gov ID
- NCT00420862
- Acronym / sponsor ID
- DANTE
- Conditions
- Lung Cancer
- Keywords
- Lung neoplasms, Early diagnosis, Screening, Spiral Computed Tomography, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2,400 participants
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Lega Italiana per la Lotta contro i Tumori
- Study start
- Jun 2001
- Study completion
- Feb 2010
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 74 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiral Computed Tomography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2007.
- Derived from this study: PubMed 17936405Infante 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianni Ravasi, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spiral Computed Tomography in people with Lung Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00420862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2007.