NCT00445718 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2017-02-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

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
healthy Volunteers: false
maximum Age: 6 Months
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: CHILD
study Population: Patients with sonographically identified adrenal mass

Treatment arms and interventions

arm Groups

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.
intervention Names
Procedure: computed tomography
Procedure: 3-Tesla magnetic resonance imaging
Procedure: Abdominal Sonogram
label
Observational

interventions

arm Group Labels
Observational
name
computed tomography
other Names
tomography, computed
type
PROCEDURE
arm Group Labels
Observational
name
3-Tesla magnetic resonance imaging
other Names
3-Tesla MRI
3T MRI
type
PROCEDURE
arm Group Labels
Observational
description
Sonogram of the abdomen area
name
Abdominal Sonogram
type
PROCEDURE

Study design

observational Model: CASE_ONLY
time Perspective: PROSPECTIVE

Enrollment

count: 97
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Estimated using the Kaplan-Meier method.
measure
Survival rate
time Frame
Up to 3 years
description
Estimated using the Kaplan-Meier method.
measure
Event-free survival (EFS)
time Frame
Up to 3 years

Full study description

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.

Source references

references

citation
Nuchtern 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
type
DERIVED

Source notices and limitations

Discovery and provenance

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<p id="_823" tabindex="-1">Evidence (observation without biopsy):</p> <div class="pdq-content-list"><ol id="_824"><li>The <a href="/clinicaltrials/NCT00445718">COG-ANBL00P2 (NCT00445718)</a> study reported that expectant observation is safe in patients younger than 6 months with solid adrenal tumors smaller than 3.1
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1">Evidence (observation without biopsy):</p> <div class="pdq-content-list"><ol id="_824"><li>The <a href="/clinicaltrials/NCT00445718">COG-ANBL00P2 (NCT00445718)</a> study reported that expectant observation is safe in patients younger than 6 months with solid adrenal tumors smaller than 3.1 cm (or cystic tumors small
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Neuroblastoma Treatment (PDQ®)–Health Professional Version
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context
Updated: April 28, 2025
datetime
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display
April 28, 2025
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Preserved source evidence · Not medical advice