Genetic Susceptibility Biomarkers in Children With Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])
- Conditions
- Neuroblastoma
- Interventions
- Other: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker AnalysisOther: Questionnaire Administration
- Registration Number
- NCT01119560
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
This research trial studies the genes biomarkers in children with neuroblastoma. Studying the genes in a child's cancer cells may help doctors improve ways to diagnose and treat children with neuroblastoma.
- Detailed Description
PRIMARY OBJECTIVES:
I. Evaluate the independent association of common genetic polymorphisms involved in folate, vitamin A, and related metabolic and transport pathways and the risk of neuroblastoma (NB).
II. Evaluate the joint effects of multiple genes on the risk of NB. III. Evaluate the effects of gene-exposure interactions on the risk of NB. IV. Evaluate genetic effects within NB subgroups defined by age at diagnosis and a Children?s Oncology group classification schema based on age, v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) oncogene status, histology, and deoxyribonucleic acid (DNA) ploidy.
V. Recontact mothers of participating NENA case children, conduct brief web-based screen to ascertain whether the pregnancy including the index NENA child was a multiple (twin, triplet, etc), whether the mother knew if the children were monozygotic (MZ) or dizygotic (DZ), and obtain a complete pregnancy history.
VI. Request a saliva sample from the other twin/multiple sibling of the NENA child.
VII. Extract DNA from saliva samples and securely store. VIII. Clean new survey data and merge with main NENA study database.
OUTLINE:
The biologic mother of the patient is asked to complete a Diet History Questionnaire about diet during pregnancy, and information on demographics, lifestyle factors, medication used during pregnancy, history of breast feeding, and family history of cancer or birth defects. Parents are given ORAgene saliva collection kits for self-collection. Saliva bio-specimen samples are collected from both biologic parents and the patient. Tissue samples previously stored in a tissue bank are obtained for deceased patients, if available. DNA is extracted from samples, amplified and analyzed using real-time polymerase chain reaction (PCR) quantitation assay, and genotyped using single nucleotide polymorphisms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
- Primary diagnosis of neuroblastoma made at a North American COG institution
- Diagnosed between 12/24/2007- 7/31/2013
- Diagnosed at < 6 years of age
- Biological mother is alive and willing to participate
- Questionnaire respondents must understand English or Spanish
- Are only those participating in CCRN who have agreed to be contacted for future studies
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (Questionnaire, saliva & tissue sample) Laboratory Biomarker Analysis The biologic mother of the patient is asked to complete a Diet History Questionnaire about diet during pregnancy, and information on demographics, lifestyle factors, medication used during pregnancy, history of breast feeding, and family history of cancer or birth defects. Parents are given ORAgene saliva collection kits for self-collection. Saliva bio-specimen samples are collected from both biologic parents and the patient. Tissue samples previously stored in a tissue bank are obtained for deceased patients, if available. DNA is extracted from samples, amplified and analyzed using real-time PCR quantitation assay, and genotyped using single nucleotide polymorphisms. Ancillary-Correlative (Questionnaire, saliva & tissue sample) Cytology Specimen Collection Procedure The biologic mother of the patient is asked to complete a Diet History Questionnaire about diet during pregnancy, and information on demographics, lifestyle factors, medication used during pregnancy, history of breast feeding, and family history of cancer or birth defects. Parents are given ORAgene saliva collection kits for self-collection. Saliva bio-specimen samples are collected from both biologic parents and the patient. Tissue samples previously stored in a tissue bank are obtained for deceased patients, if available. DNA is extracted from samples, amplified and analyzed using real-time PCR quantitation assay, and genotyped using single nucleotide polymorphisms. Ancillary-Correlative (Questionnaire, saliva & tissue sample) Questionnaire Administration The biologic mother of the patient is asked to complete a Diet History Questionnaire about diet during pregnancy, and information on demographics, lifestyle factors, medication used during pregnancy, history of breast feeding, and family history of cancer or birth defects. Parents are given ORAgene saliva collection kits for self-collection. Saliva bio-specimen samples are collected from both biologic parents and the patient. Tissue samples previously stored in a tissue bank are obtained for deceased patients, if available. DNA is extracted from samples, amplified and analyzed using real-time PCR quantitation assay, and genotyped using single nucleotide polymorphisms.
- Primary Outcome Measures
Name Time Method Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB Up to 4 years Stratified on the exposure variable and the strength of associations between strata by using a chi-square based test of heterogeneity.
Gene-environment interactions Up to 4 years Stratified on the exposure variable and comparing the strength of associations between strata by using a chi-square-based test of heterogeneity.
Genetic polymorphisms involved in folate, vitamin A, and related metabolic and transport pathways with the risk of neuroblastoma (NB) Up to 4 years The distributions of the estimated dietary and vitamin intake will be assessed and categories defined using quantiles and confirmation by nonparametric splines. Evaluated under a recessive or log-additive transmission model.
Genetic effects within NB subgroups defined by age at diagnosis and a Children?s Oncology group classification schema based on age, MYCN oncogene status, histology, and deoxyribonucleic acid (DNA) ploidy Up to 4 years Because the log-linear models involve calculating a likelihood, the Bayesian information criterion, a likelihood-based model selection criterion will be used.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (153)
Children's Healthcare of Atlanta - Egleston
🇺🇸Atlanta, Georgia, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
NYU Winthrop Hospital
🇺🇸Mineola, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Janeway Child Health Centre
🇨🇦Saint John's, Newfoundland and Labrador, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Miller Children's and Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Lurie Children's Hospital-Chicago
🇺🇸Chicago, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Saint Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
USA Health Strada Patient Care Center
🇺🇸Mobile, Alabama, United States
Nemours Children's Clinic-Jacksonville
🇺🇸Jacksonville, Florida, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
University of Florida Health Science Center - Gainesville
🇺🇸Gainesville, Florida, United States
Michigan State University Clinical Center
🇺🇸East Lansing, Michigan, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Alfred I duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Nemours Children's Clinic - Pensacola
🇺🇸Pensacola, Florida, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Advocate Children's Hospital-Oak Lawn
🇺🇸Oak Lawn, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Kentucky/Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Columbia University/Herbert Irving Cancer Center
🇺🇸New York, New York, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Helen DeVos Children's Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
🇺🇸New Hyde Park, New York, United States
Saint Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
University of Missouri - Ellis Fischel
🇺🇸Columbia, Missouri, United States
Novant Health Presbyterian Medical Center
🇺🇸Charlotte, North Carolina, United States
Saint Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Natalie Warren Bryant Cancer Center at Saint Francis
🇺🇸Tulsa, Oklahoma, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Mercy Children's Hospital
🇺🇸Toledo, Ohio, United States
East Tennessee Childrens Hospital
🇺🇸Knoxville, Tennessee, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
🇺🇸Houston, Texas, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
UCSF Medical Center-Parnassus
🇺🇸San Francisco, California, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Ascension Saint John Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
🇺🇸Denver, Colorado, United States
Legacy Emanuel Children's Hospital
🇺🇸Portland, Oregon, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
🇺🇸Tampa, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Children's Hospital and Medical Center of Omaha
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
🇺🇸Downey, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Lucile Packard Children's Hospital Stanford University
🇺🇸Palo Alto, California, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Saint Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Rainbow Babies and Childrens Hospital
🇺🇸Cleveland, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
BI-LO Charities Children's Cancer Center
🇺🇸Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Cardinal Glennon Children's Medical Center
🇺🇸Saint Louis, Missouri, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Mission Hospital Inc-Memorial Campus
🇺🇸Asheville, North Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Lehigh Valley Hospital - Muhlenberg
🇺🇸Bethlehem, Pennsylvania, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Penn State Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Texas Tech University Health Sciences Center-Amarillo
🇺🇸Amarillo, Texas, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Mary Bridge Children's Hospital and Health Center
🇺🇸Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
UF Cancer Center at Orlando Health
🇺🇸Orlando, Florida, United States
Norton Children's Hospital
🇺🇸Louisville, Kentucky, United States
C S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
The Childrens Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
University of Rochester
🇺🇸Rochester, New York, United States
Children's Hospital
🇨🇦London, Ontario, Canada