Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma

Official Title

LEAHRN (Late Effects After High-Risk Neuroblastoma) Study

Summary:

This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.

Trial Description

Primary Outcome:

• Prevalence of specific late effects
• Prevalence of subsequent malignant neoplasm (SMN)
• Risk factors
• Prognostic of decreased Pediatric Quality of Life (PedsQL) score

Secondary Outcome:

• Collection and storage of blood samples

PRIMARY OBJECTIVES:

• To estimate the prevalence of organ dysfunction, subsequent malignant neoplasm (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction in a large cohort of representative 5-year survivors of high-risk neuroblastoma treated with modern therapy.
• To identify the demographic, clinical and treatment-related risk factors associated with increased risk of organ dysfunction, SMN, growth impairment, abnormal pubertal development and neurobehavioral dysfunction in long-term survivors of high-risk neuroblastoma.
• To explore the impact of new biologic therapies and diagnostics including immunotherapy, immunocytokines, isotretinoin (cis-retinoic acid) and iobenguane I-131 (131 I-MIBG) on the risk of late effects.
• To determine the impact of impaired organ function, physical growth, pubertal development, and neurobehavioral function on health-related quality of life (HRQOL) in long-term survivors of high-risk neuroblastoma.

SECONDARY OBJECTIVES:

• To establish a cohort of high-risk neuroblastoma survivors, with stored peripheral blood samples, who were treated with multi-modal therapies since the year 2000 as a resource for future investigation.

OUTLINE: Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.

View this trial on ClinicalTrials.gov