NCT00999622

Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma

CD4 Count And Risk Of Infection In Patients With Brain Tumors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Brain and Central Nervous System Tumors
• Infection

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	questionnaire administration

Timeline

• Start date: 2004-07-01
• Primary completion: 2009-08-01
• First posted: 2009-10-22
• Last updated: 2012-05-28