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Status:

COMPLETED

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Adrenocortical Carcinoma

Localized Resectable Neuroblastoma

Eligibility:

All Genders

Up to 6 years

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 tes...

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 OBJECTIVE...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2001

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2013

    Estimated Enrollment :

    97 Patients enrolled

    Trial Details

    Trial ID

    NCT00445718

    Start Date

    July 1 2001

    End Date

    January 1 2013

    Last Update

    February 9 2017

    Active Locations (45)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (45 locations)

    1

    University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724

    2

    Southern California Permanente Medical Group

    Downey, California, United States, 90242

    3

    Children's Hospital Los Angeles

    Los Angeles, California, United States, 90027

    4

    Children's Hospital Colorado

    Aurora, Colorado, United States, 80045