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

Completed

Conditions studied: Adrenocortical Carcinoma, Localized Resectable Neuroblastoma, Precancerous Condition

In brief

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.

Key facts

Study ID

NCT00445718

Run by

Children's Oncology Group

People needed

97

Starts

2001-07-01

Expected to finish

2013-01-01

Last updated by the study team

2017-02-09

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• No evidence of disease outside the adrenal gland by 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

Where it is running

• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Childrens Memorial Hospital — Chicago, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Maine Children's Cancer Program — Scarborough, Maine, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Saint Joseph's Regional Medical Center — Paterson, New Jersey, United States
• Brooklyn Hospital Center — Brooklyn, New York, United States
• The Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Mission Hospitals Inc — Asheville, North Carolina, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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