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CEA als biomarker bij longcarcinoom


- candidate number24523
- NTR NumberNTR5921
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jun-2016
- Secondary IDsW16.042 MEC-U te Nieuwegein.
- Public TitleCEA als biomarker bij longcarcinoom
- Scientific TitlePrognostic value of serum carcinoembryonic antigen in advanced (non-)small cell lung cancer
- ACRONYMCEA
- hypothesisCarcinoembryonic antigen (CEA) is used as a biomarker in colon carcinoma, however in patients with (non-)small cell lung cancer ((N)SCLC) increased serum CEA levels commonly found. Since decline of high CEA levels in colon carcinoma is predictive for objective response (OR), it is hypothesised that (N)SCLC is associated with increased CEA concentrations and decreases in CEA levels have prognostic value for therapy response.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC), Biomarkers, CEA
- Inclusion criteriaI. Advanced (N)SCLC patients who received conventional chemotherapy, targeted therapy or immunotherapy between 2009-2016.
II. CEA levels available prior to treatment (baseline), on week 3, 6 and 12.
- Exclusion criteriaSubjects who do not meet inclusion criteria.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-jul-2016
- planned closingdate1-jan-2017
- Target number of participants500
- InterventionsRetrospective observational study
- Primary outcomeCorrelation of CEA decline (when CEA initially is increased (>5.0 ng/mL)) and OR (conform RECIST 1.1 criteria).
- Secondary outcomeI. The correlation of decline of CEA levels and overall survival (OS).
II. The correlation of decline of CEA levels and the occurrence of brain metastases.
III. The correlation of decline of CEA levels and OR on different treatment strategies (conventional chemotherapy, targeted therapy and immunotherapy).
- TimepointsCEA levels prior to treatment (baseline), on week 3, 6 and 12.
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D. C. de Jong
- CONTACT for SCIENTIFIC QUERIES D. C. de Jong
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- Publications
- Brief summaryRetrospective observational study to evaluate the association between changes in CEA levels and objective response (OR), overall survival (OS) and presence or occurance of brain metastasis during first-line conventional chemotherapy, targeted therapy or immunotherapy in patients with advanced (N)SCLC.
- Main changes (audit trail)
- RECORD28-jun-2016 - 8-aug-2016


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