ACTIVE_NOT_RECRUITING

Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

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Conditions

GanglioneuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaRegional NeuroblastomaStage 4 NeuroblastomaStage 4S Neuroblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Official Title

Neuroblastoma Biology Studies

Quick Facts

Study Start:2000-11-06
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT00904241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
  2. * There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
  3. * Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
  4. * Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
  5. * It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
  6. * Exceptions
  7. * In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
  8. * For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
  9. * For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
  10. * Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
  11. * Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
  12. * All patients and/or their parents or legal guardians must sign a written informed consent
  13. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  1. * Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol

Contacts and Locations

Principal Investigator

Michael Hogarty
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
Cardon Children's Medical Center
Mesa, Arizona, 85202
United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
United States
Valley Children's Hospital
Madera, California, 93636
United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
United States
Sutter Medical Center Sacramento
Sacramento, California, 95816
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Rady Children's Hospital - San Diego
San Diego, California, 92123
United States
Naval Medical Center -San Diego
San Diego, California, 92134
United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143
United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102
United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Yale University
New Haven, Connecticut, 06520
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010
United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
United States
Lee Memorial Health System
Fort Myers, Florida, 33901
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
Florida Hospital Orlando
Orlando, Florida, 32803
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806
United States
Nemours Children's Hospital
Orlando, Florida, 32827
United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
Saint Mary's Hospital
West Palm Beach, Florida, 33407
United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859
United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois
Chicago, Illinois, 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
United States
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260
United States
Blank Children's Hospital
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Ascension Saint John Hospital
Detroit, Michigan, 48236
United States
Michigan State University Clinical Center
East Lansing, Michigan, 48824-7016
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008
United States
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, 48073
United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Columbia Regional
Columbia, Missouri, 65201
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
United States
Overlook Hospital
Summit, New Jersey, 07902
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
United States
Albany Medical Center
Albany, New York, 12208
United States
Brooklyn Hospital Center
Brooklyn, New York, 11201
United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
NYU Winthrop Hospital
Mineola, New York, 11501
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
United States
Mount Sinai Hospital
New York, New York, 10029
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
United States
New York Medical College
Valhalla, New York, 10595
United States
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, 28801
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606
United States
Mercy Children's Hospital
Toledo, Ohio, 43608
United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, 44501
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136
United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
United States
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403
United States
East Tennessee State University
Johnson City, Tennessee, 37614-0054
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
El Paso Children's Hospital
El Paso, Texas, 79905
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Covenant Children's Hospital
Lubbock, Texas, 79410
United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Carilion Clinic Children's Hospital
Roanoke, Virginia, 24014
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Kaiser Permanente Washington
Seattle, Washington, 98112
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304
United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Michael Hogarty, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2000-11-06
Study Completion DateN/A

Study Record Updates

Study Start Date2000-11-06
Study Completion DateN/A

Terms related to this study

Additional Relevant MeSH Terms

  • Ganglioneuroblastoma
  • Localized Resectable Neuroblastoma
  • Localized Unresectable Neuroblastoma
  • Regional Neuroblastoma
  • Stage 4 Neuroblastoma
  • Stage 4S Neuroblastoma