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

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00445718

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/Nonmalignant 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:

MedlinePlus related topics: Cancer MRI Scans Neuroblastoma

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
Estimated Primary Completion Date:	March 2007 (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 143 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

No publications provided

Study ID Numbers:	CDR0000078643, COG-ANBL00P2
Study First Received:	March 7, 2007
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00445718 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adrenocortical carcinoma
localized resectable neuroblastoma
precancerous/nonmalignant condition

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Precancerous Conditions
Adrenocortical Carcinoma
Neoplasms, Nerve Tissue
Endocrine System Diseases
Adrenal Gland Diseases
Neuroblastoma
Carcinoma
Neuroectodermal Tumors
Neoplasms

Neoplasms by Site
Adrenal Gland Neoplasms
Neoplasms, Germ Cell and Embryonal
Adrenal Cortex Neoplasms
Adrenal Cortex Diseases
Adenocarcinoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2009