Establish the clinical value of a molecular sputum test for the diagnosis of lung cancer.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary research variables
A) Establish effect of prolonged sputum sampling on sensitivity for diagnosis
of lung cancer.
B) Establish clinical sensitivity and specificity of molecular sputum test for
the diagnosis of lung cancer in symptomatic patients, and comparison of
molecular test with cytological examination.
C) Establish clinical sensitivity and specificity of molecular sputum test for
early diagnosis of lung cancer
Secondary outcome
A) Establish in subpopulation analysis of exhaled air.
B) Establish in subpopulation analysis molecular markers in blood for
comparison with sputum.
Background summary
Background.
Lung cancer is the most fatal cancer in the western world. The 5 year survival
is about 12%. Whether secondary prevention by high resolution CT (HRCT
screening, NELSON study) will reduce mortality is not known yet. Disadvantages
of this method are the high costs, and low specificity. Possibly molecular
sputum analysis may be used to identify people high risk at high risk for or
diagnosis of lung cancer.
Study objective
Establish the clinical value of a molecular sputum test for the diagnosis of
lung cancer.
Study design
In a population of people with increased risk for the diagnosis of lung cancer
(COPD) and in patients in the work up for the diagnosis of *lung cancer* sputum
will be collected for a period of 9 days, pooled in samples of 3 days, leading
to 3 sequential samples in each patient. Molecular analysis and cytological
will be performed on the sputum samples in a blinded fashion.
A) Sputum of 3, 6 and 9 days will be used to determine the effect of this
sampling on the sensitivity for diagnosis of lung cancer.
B) Comparison of the sputum analysis from lung cancer patients with COPD will
reveal clinical sensitivity and specificity. The test outcome will be compared
with cytological analysis.
C) The same test will be performed on samples from a sputum bank collected in
the scope of the NELSON study of first round participants. This sputum bank has
been collected and largely exits of people at risk and a limited number of
asymptomatic lung cancer patients.
Study burden and risks
Risk estimation The risk of this study is estimated to be neglectable. The
contribution of the patients is minor, as this consists of sputum collection
and posting the box with 3 sampling vials.
Exhaled air risk is neglectable. For subgroup also additional venous blood
puncture, performed for routine medical care.
De Boeleaan 1117
1081 HV Amsterdam
NL
De Boeleaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
patients suspicious of lung cancer;
Patients with progression of lung cancer after treatment
Exclusion criteria
No
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22206.029.08 |