Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496977
Status:
UNKNOWN
Last Update Posted:
2007-07-06
First Post:
2007-07-05
Brief Title:
Danish Lung Cancer Screening Trial DLCST
Sponsor:
Danish Lung Cancer Group
Organization:
Danish Lung Cancer Group
Study Overview
Official Title:
Screening for Lung Cancer A Randomised Controlled Trial of Low-Dose CT-Scanning
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DLCST
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
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 ie 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 eg morbidity hospitalization GP consultations etc
Assess the value of PET scanning when screening for lung cancer
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 eg morbidity hospitalization GP consultations etc
Assess the value of PET scanning when screening for lung cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None