Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00445718
First received: March 7, 2007
Last updated: April 25, 2014
Last verified: April 2014
  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: 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 ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.

  • Event-free survival (EFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.


Enrollment: 97
Study Start Date: July 2001
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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445718

  Show 45 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jed Nuchtern, MD Children's Oncology Group
  More Information

No publications provided by Children's Oncology Group

Additional 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, CDR0000078643, COG-ANBL00P2, U10CA098543
Study First Received: March 7, 2007
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014