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Evaluation of l-caldesmon as biomarker for brain tumor monitoring

Projectomschrijving

Het doel van dit onderzoek was 'het bepalen van de effectiviteit van l-Caldesmon (l-CaD) als biomarker in de behandeling en follow-up van glioom patienten (in het verminderen van het aantal MRI scans)'.

Verslagen


Eindverslag

Serum samples van glioom patienten als beschreven in project voorstel 5088 zijn verzameld(totaal 100 patienten). We verwachten de eerste resultaten van de l-caldesmon immunoassay eind 2008. We hebben vastgesteld dat de concentratie L-caldesmon in plasma relatief laag is vergeleken met een HELA cell extract. De waargenomen signalen zijn te laag voor een robuuste commerciele immunoassay op dit moment. Fuji Rebio ontwikkelt en verbetert de immunoassay techniek op dit moment. Gebruik makend van Western Blotting kan L-caldesmon aangetoond worden in 2 ml plasma verkregen van glioom patienten. Deze hoeveelheid plasma is te veel om reguliere en commerciele immunoassays te ontwikkelen. We voorzien dat we dit item kunnen oplossen door de immunoassay te verbeteren (betere antilichamen) en selective reaction monitoring techniek toe te passen in een recent aangekochte massa spectrometer.

Samenvatting van de aanvraag

Objectives: The goal is to determine the value of l-CaD as a biomarker in the treatment and follow-up of glioma patients. We will address the following aims: 1) Determine the correlation between serum l-CaD levels and MRI-based MacDonald response criteria in individual glioma patients. 2) Determine the correlation between tumor volume observed in MRI and serum l-CaD levels. We envision a reduction of 50% in the number of MRI scans performed during treatment and follow-up. Study design: Prospective cohort study. Study population: A total of 130 glioma patients will be included in the study. The patients are divided into 3 groups: 1. Fifty patients with high-grade glioma in a good clinical condition. 2. Fifty patients with a high grade glioma in poor clinical condition. 3. Thirty patients with recurrent or progressive glioma who are treated with chemotherapy. Intervention: Measurement of serum l-CaD levels at all MRI scan points. Outcome measures: Serum l-CaD levels; MacDonald response criteria; tumor volume on MRI. Power / data analysis: 1. For group analysis, all samples will be divided into 3 groups: 1) baseline samples; 2) all samples drawn when the patient was responding (PR & CR) or had stable disease (SD); and 3) the samples drawn at the time of progression (PD). Differences in mean l-CaD will be tested with a two-sided T-test. 2. For individual patient-based analysis, the l-CaD values will be expressed as percentage increase/decrease compared to the base line. For use as a biomarker in response and follow-up, a predictive value of >95% will be required. 3. The l-CaD serum levels will be correlated to the calculated tumor volume, using a Pearson correlation test. Economics: Serum l-CaD determination may replace 2200 MRI scans per year in the follow-up and treatment of glioma patients. At an estimated average cost of Euro 200 pro MRI and a cost of Euro 10-15 for serum l-CaD examination, a cost-reduction of Euro 400,000.00 per year is anticipated. Time: 24 months

Onderwerpen

Kenmerken

Projectnummer:
94527040
Looptijd: 100%
Looptijd: 100 %
2007
2009
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
Dr. drs. T.M. Luider
Verantwoordelijke organisatie:
Erasmus MC