Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging
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| ClinicalTrials.gov Identifier: NCT00445718 |
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Recruitment Status :
Completed
First Posted : March 9, 2007
Last Update Posted : February 9, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Adrenocortical Carcinoma Localized Resectable Neuroblastoma Precancerous Condition | Procedure: computed tomography Procedure: 3-Tesla magnetic resonance imaging Procedure: Abdominal Sonogram |
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 |
| Actual Enrollment : | 97 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study |
| Study Start Date : | July 2001 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Observational
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.
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Procedure: computed tomography
Other Name: tomography, computed Procedure: 3-Tesla magnetic resonance imaging Other Names:
Procedure: Abdominal Sonogram Sonogram of the abdomen area |
- Survival rate [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- Event-free survival (EFS) [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | up to 6 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445718
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| Principal Investigator: | Jed Nuchtern, MD | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00445718 |
| Other Study ID Numbers: |
ANBL00P2 NCI-2009-00398 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ANBL00P2 ( Other Identifier: Children's Oncology Group ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 9, 2007 Key Record Dates |
| Last Update Posted: | February 9, 2017 |
| Last Verified: | February 2017 |
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Neuroblastoma Precancerous Conditions Adrenocortical Carcinoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Adenocarcinoma Carcinoma Adrenal Cortex Neoplasms Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases |