|No phase specified||Natural history/Epidemiology||Closed||6 months and under||NCI, Other||ANBL00P2|
NCI-2009-00398, CDR0000078643, COG-ANBL00P2, U10CA098543, NCT00445718
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.
Further Study Information
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%.
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.
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 study.
Patients are followed within 1 week and then every 6 months for 3 years.
- Sonographically identified adrenal mass meeting one of the following criteria:
- No greater than 16 mL in volume, if solid
- No greater than 65 mL if at least 25% cystic and does not cross the midline
- Disease limited to the adrenal gland
- No evidence of positive contralateral or ipsilateral lymph nodes or other spread outside the adrenal gland by CT scan or MRI
- Negative for neuroblastoma cells by bone marrow aspirate
- No evidence of disease outside the adrenal gland by bone scan (+/-MIBG scan)
- Negative for tumor cells by bone marrow biopsy, if performed
- No more than 6 months of age on the date the mass is first identified
- No prior chemotherapy
- No prior abdominal surgery
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Jed Nuchtern, MD||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00445718
ClinicalTrials.gov processed this data on March 03, 2014
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