Evaluation of l-caldesmon as biomarker for brain tumor monitoring
02 / 2007 - 02 / 2009
Objective:The overall goal is to determine the value of l-CaD as a serum biomarker in the treatment and follow-up of glioma patients. To reach this goal, we will address the following aims: 1) What is the correlation between serum l-CaD levels and the classical MRI-based MacDonald response criteria in individual patients? 1a) Determine cut-off values for relevant changes (increase / decrease) in l-CaD serum levels;1b) Determine the positive and negative predictive value of changes in serum l-CaD levels for progressive disease, partial response, complete response and stable disease?2) What is the correlation between tumor volume and serum l-CaD levels in this group of patients?2a) Determine the volume of enhancing tumor on all MRI scans (if time allows);2b) Correlate l-CaD serum levels with tumor volumes. Samenvatting 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.