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Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study
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.
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 1, 2001
Primary Completion Date
January 1, 2013
Completion Date
January 1, 2013
Last Updated
February 9, 2017
97
ACTUAL participants
computed tomography
PROCEDURE
3-Tesla magnetic resonance imaging
PROCEDURE
Abdominal Sonogram
PROCEDURE
Lead Sponsor
Children's Oncology Group
Collaborators
NCT03050268
NCT00453674
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05563467