Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma
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|ClinicalTrials.gov Identifier: NCT00999622|
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : May 28, 2012
RATIONALE: Gathering information over time from laboratory tests of patients with newly diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect of treatment on white blood cell count and the risk of infection.
PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with newly diagnosed malignant supratentorial astrocytoma.
|Condition or disease||Intervention/treatment|
|Brain and Central Nervous System Tumors Infection||Other: laboratory biomarker analysis Other: questionnaire administration|
- Determine the frequency and severity of decreases in CD4 counts as a function of therapy in patients with newly diagnosed malignant astrocytoma.
- Determine whether the decrease in CD4 counts is a significant predictor of infections or adverse outcomes in these patients.
OUTLINE: This is a multicenter study.
Patients undergo monthly collection of blood for serial CD4 counts and heme-8 with differential for 1 year for quantitative analysis. Patients also complete a monthly questionnaire about infections and antibiotic use.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 125 patients (100 with high-grade disease and 25 with low-grade disease) will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Observational Model:||Case Control|
|Official Title:||CD4 Count And Risk Of Infection In Patients With Brain Tumors|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||August 2009|
- Frequency and severity of decreases in CD4 counts [ Time Frame: 1 year ]
- Determination of decrease in CD4 counts as significant predictor of infections or adverse outcomes [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999622
|Study Chair:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|