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Danish Lung Cancer Screening Trial (DLCST) (DLCST)

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ClinicalTrials.gov Identifier: NCT00496977
Recruitment Status : Unknown
Verified June 2007 by Danish Lung Cancer Group.
Recruitment status was:  Active, not recruiting
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
Sponsor:
Collaborator:
Ministry of the Interior and Health, Denmark
Information provided by:
Danish Lung Cancer Group

Brief Summary:
The trial is a randomised trial comparing annual CT screening for lung cancer with no screening in 4104 smokers and former smokers between the age of 50 and 70 years. The goals are: 1) to evaluate if annual CT screening can reduce lung cancer mortality by more than 20 % (in collaboration with the NELSON trial in the Netherlands, 2) to evaluate psychological effects of screening including the effects of false positive diagnoses, and 3) to evaluate possible effects on smoking behaviour. The trial is funded in full by the Danish Ministry of Interior and Health.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: annual CT screening Not Applicable

Detailed Description:

The trial is a parallel randomized controlled trial comparing either a yearly low dose CT scan or no screening. It is scheduled to enroll 4000 smokers and former smokers, and the study is scheduled to last 5 years, i.e. an initial (prevalence) screening is followed by 4 annual (incidence) screenings.

In addition the following investigations are done: A prospective, longitudinal questionnaire assessment of enrolled participants who have received a false positive diagnosis. The questionnaire will focus on the consequences of receiving a false positive diagnosis. Answers from enrolled subjects who have received a false positive diagnosis will be compared to their own “baseline” responses, and responses from subjects who have received a negative result of their own low-dose CT scans All participants will annually be questioned regarding smoking habits, their motivation for cessation of smoking and will be advised to refrain from smoking to assess the effect of participation in a screening protocol for lung cancer on cessation of smoking.

Socioeconomic consequences of screening for lung cancer will be assessed by longitudinal registration of costs and benefits (e.g. morbidity, hospitalization, GP consultations etc.

Assess the value of PET scanning when screening for lung cancer.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Screening
Official Title: Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.
Study Start Date : October 2004
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Lung cancer mortality [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. lung cancer incidense and stagedistribution [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoking exposure > 20 pack years
  • Quit smoking < 10 years
  • Fit to undergo treatment
  • Pulmonary function test > 30 % of expected (FEV1)

Exclusion Criteria:

  • Bodyweight > 130 Kg
  • Formely treated for lungcancer, breastcancer, melanoma or hypernephroma.
  • Serious co-morbidity with life expectancy below 10 years.
  • Treated for other malignant diseases within the last 5 years.
  • Treatment for pulmonary tuberculosis within the last 2 years.

Information from the National Library of Medicine

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): NCT00496977


Locations
Denmark
Lung Screening Clinic, Gentofte University Hospital
Hellerup, Denmark, DK-2900
Sponsors and Collaborators
Danish Lung Cancer Group
Ministry of the Interior and Health, Denmark
Investigators
Principal Investigator: Jesper H Pedersen, MD, Dr.Sci Gentofte University Hospital, Hellerup, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00496977     History of Changes
Other Study ID Numbers: KA-02045
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: June 2007

Keywords provided by Danish Lung Cancer Group:
lung cancer
CT scan
screening

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases