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Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.

50 Years
70 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Screening for Lung Cancer. A Randomised Controlled Trial of Low-Dose CT-Scanning.

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Screening

Outcome Measure:

Lung cancer mortality

Outcome Time Frame:

10 years

Principal Investigator

Jesper H Pedersen, MD, Dr.Sci

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gentofte University Hospital, Hellerup, Denmark


Denmark: Danish Dataprotection Agency

Study ID:




Start Date:

October 2004

Completion Date:

January 2010

Related Keywords:

  • Lung Cancer
  • lung cancer
  • CT scan
  • screening
  • Lung Neoplasms