Clinical trial · Observational
Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging
Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study
NCT00445718CI-TRIAL-00025884completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
| Localized Resectable Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-Tesla magnetic resonance imaging | Procedure | — | UNRESOLVED |
| Abdominal Sonogram | Procedure | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Procedure: computed tomography
- Procedure: 3-Tesla magnetic resonance imaging
- Procedure: Abdominal Sonogram
Primary outcomes (2)
- measure
- Survival rate
- timeFrame
- Up to 3 years
- description
- Estimated using the Kaplan-Meier method.
- measure
- Event-free survival (EFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 6 Months
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNuchtern JG, London WB, Barnewolt CE, Naranjo A, McGrady PW, Geiger JD, Diller L, Schmidt ML, Maris JM, Cohn SL, Shamberger RC. A prospective study of expectant observation as primary therapy for neuroblastoma in young infants: a Children's Oncology Group study. Ann Surg. 2012 Oct;256(4):573-80. doi: 10.1097/SLA.0b013e31826cbbbd. PMID 22964741