Adrenocortical CarcinomaNCT00445718
Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging
An observational study of Adrenocortical Carcinoma and Localized Resectable Neuroblastoma, run by Children's Oncology Group at 45 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Adrenocortical Carcinoma, Localized Resectable Neuroblastoma, Precancerous Condition
- What is being tested?
- computed tomography, 3-Tesla magnetic resonance imaging and Abdominal Sonogram
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 45 sitesin 3 countries
- Study dates
- Jul 2001to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients with sonographically identified adrenal mass
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
45 sites in 3 countries.
45 sites in 3 countries
United States38 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Mission Hospitals Inc
Asheville, North Carolina, 28801
Children's Hospital Colorado
Aurora, Colorado, 80045
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Brooklyn Hospital Center
Brooklyn, New York, 11201
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403
Childrens Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Medical City Dallas Hospital
Dallas, Texas, 75230
Southern California Permanente Medical Group
Downey, California, 90242
Cook Children's Medical Center
Fort Worth, Texas, 76104
Saint Vincent Hospital
Green Bay, Wisconsin, 54301
Baylor College of Medicine
Houston, Texas, 77030
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Children's Hospital Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Baptist Hospital of Miami
Miami, Florida, 33176
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197
University of Rochester
Rochester, New York, 14642
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Maine Children's Cancer Program
Scarborough, Maine, 04074
Seattle Children's Hospital
Seattle, Washington, 98105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Southern Illinois University
Springfield, Illinois, 62702
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Canada6 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8S 4L8
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- computed tomography, 3-Tesla magnetic resonance imaging, Abdominal Sonogram
- Medical subject headings
- Adrenocortical Carcinoma, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
Also called tomography, computed
3-Tesla magnetic resonance imagingProcedure or surgery
Also called 3-Tesla MRI, 3T MRI
Abdominal SonogramProcedure or surgery
Sonogram of the abdomen area
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: computed tomography; Procedure: 3-Tesla magnetic resonance imaging; Procedure: Abdominal Sonogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Event-free survival (EFS)
Estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJul 2001
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jed Nuchtern, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445718
- Sponsor's protocol ID
- ANBL00P2
- Other IDs
- NCI-2009-00398, COG-ANBL00P2, U10CA098543
- Status last verified
- Feb 2017
- First submitted
- 7 Mar 2007
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22964741
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study
- ClinicalTrials.gov ID
- NCT00445718
- Acronym / sponsor ID
- ANBL00P2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Procedure: computed tomography, Procedure: 3-Tesla magnetic resonance imaging, Procedure: Abdominal SonogramPatients 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with sonographically identified adrenal mass
Key inclusion criteria (10 listed)
- Sonographically identified adrenal mass meeting one of the following criteria:
- Disease limited to the adrenal gland
- No more than 6 months of age on the date the mass is first identified
- No prior chemotherapy
- No prior abdominal surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomographyAlso: tomography, computed | Procedure or surgery | Observational |
| 3-Tesla magnetic resonance imagingAlso: 3-Tesla MRI, 3T MRI | Procedure or surgery | Observational |
| Abdominal SonogramSonogram of the abdomen area | Procedure or surgery | Observational |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 22964741Nuchtern 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jed Nuchtern, MD principal investigator
Children's Oncology Group
45 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenocortical Carcinoma and Localized Resectable Neuroblastoma, run by Children's Oncology Group at 45 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00445718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.