This study aims to prospectively evaluate the diagnostic properties and clinical value of the protein tumor markers CEA, CA15.3, Cyfra21.1, HE4, NSE, proGRP en SCC and the molecular tumormarkers EGFR, ALK, KRAS and BRAF in diagnosing, and monitoring…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic properties of the single markers and various combination of markers
for diagnosis of NSCLC and SCLC.
Secondary outcome
see study protocol, section 'studieopzet/eindpunten'
Background summary
Following current Dutch guidelines, lung cancer is diagnosed using chest Xray,
CT-scan or PET-CT and based on cytology or histology of tumor cells. Recent
studies show that tumor markers can have added value in diagnosing lung cancer
and in differentiating between small and non-small cell carcinoma (SCLC and
NSCLC). In addition, tumor markers may have a place in following the effect of
therapy. Differentiating NSCLC from SCLC with current diagnostics can be
time-consuming and difficult while this differentiation is important for
prognosis and choice of therapy. Aims of this study are to investigate, in a
Dutch multi-center study, whether tumormarkers have clinical value in
diagnosing, differentiation and treatment of lung cancer and in monitoring
response to therapy.
Study objective
This study aims to prospectively evaluate the diagnostic properties and
clinical value of the protein tumor markers CEA, CA15.3, Cyfra21.1, HE4, NSE,
proGRP en SCC and the molecular tumormarkers EGFR, ALK, KRAS and BRAF in
diagnosing, and monitoring of lung tumors. The hypothesis is investigated that
a correct diagnosis (including subclassification of the tumor) and prognosis
can be made more rapidly and that monitoring tumor development in response to
therapy is more precise when adding tumormarkers to the follow up. The data
gathered in the study is used to program decision support and predictive
algorithms.
Study design
prospective, observational study
Study burden and risks
No extra risk.
Small burden: per patient 30 ml of blood is drawn (1 to 21 times during max. 60
months).
Michelangelolaan 2
Eindhoven 5623ej
NL
Michelangelolaan 2
Eindhoven 5623ej
NL
Listed location countries
Age
Inclusion criteria
Patients suspected of having lung cancer that are refered to the pulmonolgy
department of one of the participating hopsitals
18 years of age or older
Exclusion criteria
Aged under 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58985.100.16 |
| OMON | NL-OMON26180 |