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

Recurrent Neuroblastoma Clinical Trial

Official title:
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. 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. II. 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. III. 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. IV. 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: I. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03057626
Study type Observational
Source Children's Oncology Group
Contact
Status Active, not recruiting
Phase
Start date June 5, 2017
Completion date September 30, 2024
View Details
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