NCT00445718

Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging

Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging. Gathering information over time from imaging and laboratory tests of infants with adrenal masses may help doctors learn more about the disease and plan the best treatment.

Detailed description

PRIMARY OBJECTIVE: I. Determine whether nonoperative management of infants with adrenal masses found on prenatal and/or neonatal imaging results in a 3-year survival rate of 95%. SECONDARY OBJECTIVES: I. Estimate the percentage of these patients who are spared surgical resection. II. Evaluate the natural history and histology of perinatal adrenal masses. III. Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas. IV. Determine the tumor characteristics that are associated with a need for resection. OUTLINE: Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3 weeks until stabilization. Patients with a continued increase in catecholamine levels or a 50% increase in tumor volume undergo surgical resection off protocol therapy. After a patient goes off-observation, they will be monitored every six months for two years, and annually thereafter.

Conditions

• Adrenocortical Carcinoma
• Localized Resectable Neuroblastoma
• Precancerous Condition

Interventions

Type	Name	Description
PROCEDURE	computed tomography
PROCEDURE	3-Tesla magnetic resonance imaging
PROCEDURE	Abdominal Sonogram	Sonogram of the abdomen area

Timeline

• Start date: 2001-07-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2007-03-09
• Last updated: 2017-02-09

Locations

45 sites across 3 countries: United States, Australia, Canada