Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445718 |
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 |
Estimated Enrollment: | 88 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Sonographically identified adrenal mass meeting one of the following criteria:
Disease limited to the adrenal gland
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Jed G. Nuchtern, MD | Baylor College of Medicine |
Study ID Numbers: | CDR0000078643, COG-ANBL00P2 |
Study First Received: | March 7, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00445718 |
Health Authority: | Unspecified |
adrenocortical carcinoma localized resectable neuroblastoma precancerous/nonmalignant condition |
Neuroectodermal Tumors, Primitive Precancerous Conditions Adrenocortical carcinoma Adrenocortical Carcinoma Endocrine System Diseases Adrenal Gland Diseases Neuroblastoma Carcinoma Neuroectodermal Tumors Adrenal Gland Neoplasms |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Endocrinopathy Adrenal Cortex Neoplasms Epinephrine Adrenal Cortex Diseases Adenocarcinoma Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |