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
4 other identifiers
observational
97
3 countries
45
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2001
Longer than P75 for all trials
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 9, 2017
February 1, 2017
11.5 years
March 7, 2007
February 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Survival rate
Estimated using the Kaplan-Meier method.
Up to 3 years
Event-free survival (EFS)
Estimated using the Kaplan-Meier method.
Up to 3 years
Study Arms (1)
Observational
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.
Interventions
Eligibility Criteria
Patients with sonographically identified adrenal mass
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (45)
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
Southern California Permanente Medical Group
Downey, California, 90242, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Mission Hospitals Inc
Asheville, North Carolina, 28801, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8S 4L8, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Related Publications (1)
Nuchtern JG, London WB, Barnewolt CE, Naranjo A, McGrady PW, Geiger JD, Diller L, Schmidt ML, Maris JM, Cohn SL, Shamberger RC. A prospective study of expectant observation as primary therapy for neuroblastoma in young infants: a Children's Oncology Group study. Ann Surg. 2012 Oct;256(4):573-80. doi: 10.1097/SLA.0b013e31826cbbbd.
PMID: 22964741DERIVED
Biospecimen
Urine, Tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jed Nuchtern, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 9, 2007
Study Start
July 1, 2001
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
February 9, 2017
Record last verified: 2017-02