Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445718
First received: March 7, 2007
Last updated: October 26, 2012
Last verified: November 2010
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Purpose
RATIONALE: 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.
PURPOSE: This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging.
| Condition | Intervention |
|---|---|
|
Adrenocortical Carcinoma Neuroblastoma Precancerous Condition |
Procedure: computed tomography Procedure: magnetic resonance imaging |
| Study Type: | Observational |
| Official Title: | Perinatal Neuroblastoma: Expectant Observation - A Children's Oncology Group Pilot Study |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 3-year survival rate
Secondary Outcome Measures:
- Natural history and histology of disease
- Tumor biology and histology of prenatal and neonatal neuroblastomas
- Tumor characteristics associated with a need for resection
| Estimated Enrollment: | 88 |
| Study Start Date: | March 2005 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- 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
- Estimate the percentage of these patients who are spared surgical resection.
- Evaluate the natural history and histology of perinatal adrenal masses.
- Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas.
- 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 study.
Patients are followed within 1 week and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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
- Negative for neuroblastoma cells by bone marrow aspirate
- No evidence of disease outside the adrenal gland by bone scan (+/-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
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior abdominal surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445718
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| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90027 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital and Research Center Oakland | |
| Oakland, California, United States, 94609 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Rady Children's Hospital - San Diego | |
| San Diego, California, United States, 92123-4282 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | |
| Aurora, Colorado, United States, 80045 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-2875 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| Sacred Heart Cancer Center at Sacred Heart Hospital | |
| Pensacola, Florida, United States, 32504 | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| Kaplan Cancer Center at St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| MBCCOP - Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-3730 | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453 | |
| Advocate Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61637 | |
| Simmons Cooper Cancer Institute | |
| Springfield, Illinois, United States, 62794-9677 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| United States, Maine | |
| Maine Children's Cancer Program at Barbara Bush Children's Hospital | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Floating Hospital for Children at Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Cardinal Glennon Children's Hospital | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Nebraska | |
| Children's Hospital | |
| Omaha, Nebraska, United States, 68114-4113 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89109-2306 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Overlook Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Albany Medical Center Hospital | |
| Albany, New York, United States, 12208-3419 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-9446 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308-1062 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106-5000 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Children's Medical Center - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Palmetto Health South Carolina Cancer Center | |
| Columbia, South Carolina, United States, 29203 | |
| Greenville Hospital Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| T.C. Thompson Children's Hospital | |
| Chattanooga, Tennessee, United States, 37403 | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37901 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113-1100 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Children's Hospital of The King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| Naval Medical Center - Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Carilion Medical Center for Children at Roanoke Community Hospital | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Providence Cancer Center at Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99220-2555 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | |
| Charleston, West Virginia, United States, 25302 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, New South Wales | |
| Westmead Institute for Cancer Research at Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Children's Hospital of Western Ontario | |
| London, Ontario, Canada, N6A 5W9 | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec, Canada, G1V 4G2 | |
| New Zealand | |
| Starship Children's Health | |
| Auckland, New Zealand, 1 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8140 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, 3010 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, 1205 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Jed G. Nuchtern, MD | Baylor College of Medicine |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00445718 History of Changes |
| Other Study ID Numbers: | CDR0000078643, COG-ANBL00P2 |
| Study First Received: | March 7, 2007 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adrenocortical carcinoma localized resectable neuroblastoma precancerous condition |
Additional relevant MeSH terms:
|
Carcinoma Neuroblastoma Precancerous Conditions Adrenocortical Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Adenocarcinoma Adrenal Cortex Neoplasms Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013