NCT03057626

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

LEAHRN (Late Effects After High-Risk Neuroblastoma) Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 376 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 5 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Neuroblastoma
• Stage 2A Neuroblastoma
• Stage 2B Neuroblastoma
• Stage 3 Neuroblastoma
• Stage 4 Neuroblastoma
• Stage 4S Neuroblastoma

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo collection of blood and urine
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2017-06-05
• Primary completion: 2021-09-30
• Completion: 2026-09-30
• First posted: 2017-02-20
• Last updated: 2026-01-09

Locations

98 sites across 4 countries: United States, Australia, Canada, New Zealand