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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyClosed6 months and underNCI, OtherANBL00P2
NCI-2009-00398, CDR0000078643, COG-ANBL00P2, U10CA098543, NCT00445718

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Jed Nuchtern, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00445718
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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