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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445718
First received: March 7, 2007
Last updated: October 26, 2012
Last verified: November 2010
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging.


Condition Intervention
Adrenocortical Carcinoma
Neuroblastoma
Precancerous Condition
 Procedure: computed tomography
Procedure: magnetic resonance imaging

Study Type: Observational
Official Title: Perinatal Neuroblastoma: Expectant Observation - A Children's Oncology Group Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 3-year survival rate

Secondary Outcome Measures:
  • Natural history and histology of disease
  • Tumor biology and histology of prenatal and neonatal neuroblastomas
  • Tumor characteristics associated with a need for resection

Estimated Enrollment: 88
Study Start Date: March 2005
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • Estimate the percentage of these patients who are spared surgical resection.
  • Evaluate the natural history and histology of perinatal adrenal masses.
  • Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas.
  • 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 study.

Patients are followed within 1 week and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
    • Negative for neuroblastoma cells by bone marrow aspirate
    • No evidence of disease outside the adrenal gland by bone scan (+/-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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior abdominal surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445718

  Show 145 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Jed G. Nuchtern, MD Baylor College of Medicine
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00445718     History of Changes
Other Study ID Numbers: CDR0000078643, COG-ANBL00P2
Study First Received: March 7, 2007
Last Updated: October 26, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adrenocortical carcinoma
localized resectable neuroblastoma
precancerous condition

Additional relevant MeSH terms:
Carcinoma
Neuroblastoma
Precancerous Conditions
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013