Research

Adrenal Masses in Infants - Pilot

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

Protocol Description

This Children's Oncology Group project involves the close monitoring and study of infants found to have a cystic or small mass in the adrenal gland, suspected of being a tumor called neuroblastoma. Although the current standard of treatment is surgical removal of the tumor, recent findings have suggested that in infants, anywhere between 33 and 100 percent of these small adrenal tumors will spontaneously resolve, disappearing on their own with no treatment. Researchers hope to determine whether, in place of surgery, it would be better to closely monitor such tumors with a combination of ultrasound imaging and urine chemistry tests to follow the growth and activity. This study will include participants from both spectrums, those choosing to have the tumor surgically removed and those choosing to be monitored. About 88 children will take part in this study from all participating Children’s Oncology Group hospitals.

Eligibility Criteria

Both male and female infants diagnosed with a cystic or small mass in the adrenal gland will be asked to participate. Participation will include both those patients who have chosen to have the mass surgically removed or to have the tumor monitored through periodic testing.
Boys: Infants up to 1 year
Girls: Infants up to 1 year

Requirements
Participants will be monitored closely with urine tests and ultrasound studies and CT/MRI imaging over approximately 2 years of study with follow up care in the third year. If there is any significant growth of the mass, or change in function, as detected, surgical removal will be recommended. Participants opting for surgical removal will only be asked for permission to review medical records and pathologist’s findings.
Visits: Evaluations will be done at varying intervals, beginning with 3-week intervals and then spaced further apart over time.
Duration: 3 years

Status: Open to Enrollment

Source of Support
Children’s Oncology Group (Study ANBL00P2)
National Cancer Institute

Additional Resources
Children’s Oncology Group CureSearch
Study Description at National Institutes of Health