ANBL00P2 -- Pilot Natural History Study of 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.
This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging.
Eligibility
Patients may be eligible for this trial if:
- Age < 6 months on the date the mass is first identified, AND the date of enrollment must be less than 120 days after the first imaging study identifying the mass, if identified postnatally, or the patient must be less than 120 days of age at time of enrollment if the first imaging study identifying the mass was prenatal.
- Sonographically identified adrenal mass which is < 16 ml in volume, if solid, or < 65 ml if at least 25% cystic, and which does not cross the midline;
- Disease must be limited to the adrenal gland:
- Abdominal CT or MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the adrenal gland
- MIBG scan negative for evidence of disease outside the adrenalgland.
- Note: A bone marrow biopsy is not required but is encouraged, if possible. If done, this biopsy should also be negative for tumor cells.
- No prior abdominal surgery or chemotherapy
Trial Sponsor
- Children’s Oncology Group (COG)
Project Begin Date
Tentative Project End Date
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