The DANTE Trial. A Randomized Study on Lung Cancer Screen... | NCT00420862

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

NCT00420862

Sponsor

Istituto Clinico Humanitas

Status

Terminated

Last Update Posted

Jan 11, 2007Estimated

Enrollment

2,400

Phase

Phase 3

Conditions

Lung Cancer

Interventions

Spiral Computed Tomography

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Not provided

Completion Date

Feb 2010

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2007

Last Update Posted Date

Jan 11, 2007Estimated

Name	Class
Lega Italiana per la Lotta contro i Tumori	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,400

Name	Type	Description	Arm Group Labels	Other Names
Spiral Computed Tomography	Procedure

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gianni Ravasi, MD	Istituto Clinico Humanitas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinico Humanitas		Rozzano	MI	20089	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17936405	Derived	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.

ID	Term
D008175	Lung Neoplasms
D004194	Disease

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms