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

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Brief Title

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

Official Title

Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

Brief 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.
    

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.
    


Study Type

Observational


Primary Outcome

Survival rate


Condition

Adrenocortical Carcinoma

Intervention

computed tomography

Study Arms / Comparison Groups

 Observational
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

97

Start Date

July 2001

Completion Date

January 2013

Primary Completion Date

January 2013

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
      

Gender

All

Ages

N/A - 6 Months

Accepts Healthy Volunteers

No

Contacts

Jed Nuchtern, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00445718

Organization ID

ANBL00P2

Secondary IDs

NCI-2009-00398

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Jed Nuchtern, MD, Principal Investigator, Children's Oncology Group


Verification Date

February 2017