The hypothesis investigated is 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 tumor markers to theā¦
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Health condition
Lung carcinoma
Research involving
Sponsors and support
Intervention
- Other 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 X-ray, 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 prospective Dutch multi-center study, whether molecular and protein tumor markers have clinical value in diagnosing, differentiation and treatment of lung cancer and in monitoring response to therapy.
Study objective
The hypothesis investigated is 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 tumor markers to the follow up. The data gathered in the study is used to program decision support and predictive algorithms.
Study design
- All patients: before diagnosis of the disease - Subset of the patients for follow-up: 1. During the diagnostic phase, before initiation of the treatment 2. 2-3 weeks after blood sample 1 3. 2-3 weeks after blood sample 2 4. 4-6 weeks after blood sample 3 5. 2-3 months after blood sample 4 6. 2-3 months after blood sample 5 7. 2-3 months after blood sample 6
Intervention
None
Esther Visser
040 239 8640
e.visser@tue.nl
Esther Visser
040 239 8640
e.visser@tue.nl
Age
Inclusion criteria
- Patients with suspected lung cancer - Aged 18 years or above
Exclusion criteria
Aged under 18 years
Design
Recruitment
IPD sharing statement
Plan description
Postbus 2500
3430 EM Nieuwegein
088 320 8784
info@mec-u.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9146 |
CCMO | NL58985.100.16 |
OMON | NL-OMON47860 |
Summary results
DOI: 10.18632/oncotarget.27664
DOI: 10.1016/j.jmoldx.2021.01.003
DOI: 10.1016/j.ctarc.2021.100410
DOI: 10.1016/j.ctarc.2021.100449