Barriers and facilitators of clinical trial enrollment in a network of community-based pediatric oncology clinics.

INTRODUCTION: Major advances in the field of pediatric oncology have resulted from rigorous, prospective clinical oncology research trials. Optimizing access for all children and adolescents to clinical research trials is an important goal. Barriers to clinical trial enrollment are numerous, involving the health care system, research infrastructure, access to care, providers, and participants. The perspectives of pediatric oncologists may provide insight into the barriers of clinical trial enrollment for this unique population. METHODS AND MATERIALS: We conducted qualitative structured interviews over two months of pediatric oncologists in a community-based clinical network as part of a quality improvement project aimed at increasing enrollment rates at St. Jude Affiliate Clinics. We assessed barriers and facilitators to clinical trial opportunities for racial and ethnic minority pediatric participants. In the same fiscal year of the interviews, we tracked clinical trial enrollment by race and ethnicity of the participant over 12 months. RESULTS: The major barriers to clinical trial enrollment for pediatric cancer minority participants included language discordance, travel difficulties, and complex trial designs. In contrast, the major facilitators included building trust with participants and their parents, and education on the merits of clinical research studies. We did not observe any disparities in clinical trial enrollment among the racial and ethnic minority participants of the clinical trials conducted across our network of pediatric oncology clinics. CONCLUSIONS: Identifying barriers and facilitators may improve clinical trial enrollment for underrepresented participant groups.

Acute immune thrombocytopenic purpura in children and adolescents in South Dakota 1998-2004.

Immune thrombocytopenic purpura (ITP), also known as idiopathic thrombocytopenic purpura, is a rare bleeding disorder caused by increased peripheral platelet destruction. The laboratory and clinical criteria for establishing the diagnosis of acute ITP in children and adolescents are widely accepted. Treatment options for ITP remain controversial. Retrospective data analysis of patients with acute ITP referred to the pediatric Hematology/Oncology Clinic at Sioux Valley Children's Specialty Clinic, seen from August 1998 to December 2004. Fourteen patients out of 25 presented with acute ITP, and had platelet count < or = 10 x 10(9)/L. Life threatening hemorrhage did not occur with any of these patients. Eleven of the analyzed 25 (44%) patients had thrombocytopenia resolve within six months of diagnosis. Nine patients (9/25, 36%) continue to be thrombocytopenic at one year from diagnosis, but without significant bleeding episodes. The clinical presentation, duration and severity of disease in patients with acute ITP seen in our Center are similar to those described in recently published studies. Our approach to treatment differed when compared with other studies. The difference in treatment may be due to patients' significant geographic distance from a tertiary care center, combined with unavailability of necessary treatment in local health institutions.

Glutathione S-transferase polymorphisms and survival in primary malignant glioma.

PURPOSE: The purpose of this research was to investigate the relationship between glutathione S-transferase (GST) polymorphisms and survival, and chemotherapy-related toxicity in 278 glioma patients. EXPERIMENTAL DESIGN: We determined genetic variants for GSTM1, GSTT1, and GSTP1 enzymes by PCR and restriction fragment length polymorphisms. We conducted Kaplan-Meier and Cox-proportional hazard analyses to examine whether the GST polymorphisms are related to overall survival, and logistic regression analysis to explore whether the GST polymorphisms are associated with toxicity. RESULTS: For patients with anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma (n = 78), patients with GSTP1*A/*A-M1 null genotype survived longer than did the rest of the group (median survival "not achieved," and 41 months, respectively; P = 0.06). Among patients treated with nitrosoureas (n = 108), those with GSTP1*A/*A and GSTM1 null genotype were 5.7 times (95% confidence interval, 0.9-37.4) more likely to experience an adverse event secondary to chemotherapy, compared with the others. CONCLUSIONS: In patients with anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma, combination of germ-line GSTP1*A/*A and GSTM1 null genotype confers a survival advantage. Patients with this genotype also have an increased risk of adverse events secondary to chemotherapy that primarily comprised nitrosourea alkylating agents.