We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445718
First Posted: March 9, 2007
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
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 Intervention
Adrenocortical Carcinoma Localized Resectable Neuroblastoma Precancerous Condition Procedure: computed tomography Procedure: 3-Tesla magnetic resonance imaging Procedure: Abdominal Sonogram

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Survival rate [ Time Frame: Up to 3 years ]
    Estimated using the Kaplan-Meier method.

  • Event-free survival (EFS) [ Time Frame: Up to 3 years ]
    Estimated using the Kaplan-Meier method.


Biospecimen Retention:   Samples With DNA
Urine, Tumor tissue

Enrollment: 97
Study Start Date: July 2001
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: tomography, computed
Procedure: 3-Tesla magnetic resonance imaging
Other Names:
  • 3-Tesla MRI
  • 3T MRI
Procedure: Abdominal Sonogram
Sonogram of the abdomen area

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sonographically identified adrenal mass
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445718


  Show 45 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jed Nuchtern, MD Children's Oncology Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00445718     History of Changes
Other Study ID Numbers: ANBL00P2
NCI-2009-00398 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ANBL00P2 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 7, 2007
First Posted: March 9, 2007
Last Update Posted: February 9, 2017
Last Verified: February 2017

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