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

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00445718
Collaborator
National Cancer Institute (NCI) (NIH)
97
Enrollment
45
Locations
138.1
Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: computed tomography
  • Procedure: 3-Tesla magnetic resonance imaging
  • Procedure: Abdominal Sonogram

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. 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.

  2. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
97 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study
Study Start Date :
Jul 1, 2001
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: computed tomography
Other Names:
  • tomography, computed

    • Procedure: 3-Tesla magnetic resonance imaging
    Other Names:
  • 3-Tesla MRI
  • 3T MRI

    • Procedure: Abdominal Sonogram
    Sonogram of the abdomen area

    Outcome Measures

    Primary Outcome Measures

    1. Survival rate [Up to 3 years]

      Estimated using the Kaplan-Meier method.

    2. Event-free survival (EFS) [Up to 3 years]

      Estimated using the Kaplan-Meier method.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Health Sciences Center Tucson Arizona United States 85724
    2 Southern California Permanente Medical Group Downey California United States 90242
    3 Children's Hospital Los Angeles Los Angeles California United States 90027
    4 Children's Hospital Colorado Aurora Colorado United States 80045
    5 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    6 Children's National Medical Center Washington District of Columbia United States 20010
    7 Baptist Hospital of Miami Miami Florida United States 33176
    8 Childrens Memorial Hospital Chicago Illinois United States 60614
    9 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    10 Southern Illinois University Springfield Illinois United States 62702
    11 Maine Children's Cancer Program Scarborough Maine United States 04074
    12 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    13 University of Massachusetts Medical School Worcester Massachusetts United States 01655
    14 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    15 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    16 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
    17 Brooklyn Hospital Center Brooklyn New York United States 11201
    18 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    19 Columbia University Medical Center New York New York United States 10032
    20 University of Rochester Rochester New York United States 14642
    21 Mission Hospitals Inc Asheville North Carolina United States 28801
    22 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    23 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    24 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    25 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    26 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    27 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
    28 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    29 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    30 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    31 Medical City Dallas Hospital Dallas Texas United States 75230
    32 Cook Children's Medical Center Fort Worth Texas United States 76104
    33 Baylor College of Medicine Houston Texas United States 77030
    34 Primary Children's Medical Center Salt Lake City Utah United States 84113
    35 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    36 Seattle Children's Hospital Seattle Washington United States 98105
    37 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    38 Saint Vincent Hospital Green Bay Wisconsin United States 54301
    39 Royal Children's Hospital Parkville Victoria Australia 3052
    40 IWK Health Centre Halifax Nova Scotia Canada B3J 3G9
    41 Chedoke-McMaster Hospitals Hamilton Ontario Canada L8S 4L8
    42 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    43 Hospital Sainte-Justine Montreal Quebec Canada H3T 1C5
    44 Centre Hospitalier Universitaire de Quebec Ste-Foy Quebec Canada G1V 4G2
    45 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jed Nuchtern, MD, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00445718
    Other Study ID Numbers:
    • ANBL00P2
    • NCI-2009-00398
    • COG-ANBL00P2
    • U10CA098543
    First Posted:
    Mar 9, 2007
    Last Update Posted:
    Feb 9, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Neuroblastoma
    Precancerous Conditions
    Adrenocortical Carcinoma

    Study Results

    No Results Posted as of Feb 9, 2017