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Genetic Susceptibility Biomarkers in Children With Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01119560
Collaborator
National Cancer Institute (NCI) (NIH)
576
Enrollment
153
Locations
118.9
Actual Duration (Months)
3.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

  1. 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).

  2. 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.

  3. 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.

  4. Request a saliva sample from the other twin/multiple sibling of the NENA child.

  5. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
576 participants
Official Title:
Genetic Susceptibility Factors in the Etiology of Neuroblastoma Also Known as Neuroblastoma Epidemiology in North America (NENA)
Actual Study Start Date :
Feb 3, 2009
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Ancillary-Correlative (Questionnaire, saliva & tissue sample)

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.

Other: Cytology Specimen Collection Procedure
Correlative studies
Other Names:
  • Cytologic Sampling

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 USA Health Strada Patient Care Center Mobile Alabama United States 36604
    3 Phoenix Childrens Hospital Phoenix Arizona United States 85016
    4 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    5 Kaiser Permanente Downey Medical Center Downey California United States 90242
    6 Loma Linda University Medical Center Loma Linda California United States 92354
    7 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    8 Children's Hospital Los Angeles Los Angeles California United States 90027
    9 Cedars Sinai Medical Center Los Angeles California United States 90048
    10 Children's Hospital and Research Center at Oakland Oakland California United States 94609-1809
    11 Kaiser Permanente-Oakland Oakland California United States 94611
    12 Children's Hospital of Orange County Orange California United States 92868
    13 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
    14 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    15 Rady Children's Hospital - San Diego San Diego California United States 92123
    16 UCSF Medical Center-Parnassus San Francisco California United States 94143
    17 Santa Barbara Cottage Hospital Santa Barbara California United States 93102
    18 Children's Hospital Colorado Aurora Colorado United States 80045
    19 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
    20 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    21 Yale University New Haven Connecticut United States 06520
    22 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    23 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    24 Children's National Medical Center Washington District of Columbia United States 20010
    25 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    26 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    27 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    28 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    29 Miami Cancer Institute Miami Florida United States 33176
    30 Florida Hospital Orlando Orlando Florida United States 32803
    31 UF Cancer Center at Orlando Health Orlando Florida United States 32806
    32 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
    33 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    34 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    35 Saint Mary's Hospital West Palm Beach Florida United States 33407
    36 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    37 Augusta University Medical Center Augusta Georgia United States 30912
    38 Memorial Health University Medical Center Savannah Georgia United States 31404
    39 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    40 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
    41 University of Illinois Chicago Illinois United States 60612
    42 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    43 Loyola University Medical Center Maywood Illinois United States 60153
    44 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
    45 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    46 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    47 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    48 Riley Hospital for Children Indianapolis Indiana United States 46202
    49 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    50 Blank Children's Hospital Des Moines Iowa United States 50309
    51 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    52 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    53 Norton Children's Hospital Louisville Kentucky United States 40202
    54 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    55 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    56 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    57 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    58 University of Massachusetts Medical School Worcester Massachusetts United States 01655
    59 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    60 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    61 Ascension Saint John Hospital Detroit Michigan United States 48236
    62 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    63 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    64 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    65 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    66 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    67 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    68 Mayo Clinic Rochester Minnesota United States 55905
    69 University of Mississippi Medical Center Jackson Mississippi United States 39216
    70 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    71 The Childrens Mercy Hospital Kansas City Missouri United States 64108
    72 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    73 Washington University School of Medicine Saint Louis Missouri United States 63110
    74 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    75 University of Nebraska Medical Center Omaha Nebraska United States 68198
    76 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    77 Hackensack University Medical Center Hackensack New Jersey United States 07601
    78 Morristown Medical Center Morristown New Jersey United States 07960
    79 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    80 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
    81 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    82 Albany Medical Center Albany New York United States 12208
    83 Roswell Park Cancer Institute Buffalo New York United States 14263
    84 NYU Winthrop Hospital Mineola New York United States 11501
    85 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    86 Columbia University/Herbert Irving Cancer Center New York New York United States 10032
    87 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    88 University of Rochester Rochester New York United States 14642
    89 State University of New York Upstate Medical University Syracuse New York United States 13210
    90 Mission Hospital Inc-Memorial Campus Asheville North Carolina United States 28801
    91 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    92 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    93 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    94 Duke University Medical Center Durham North Carolina United States 27710
    95 East Carolina University Greenville North Carolina United States 27834
    96 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    97 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    98 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    99 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    100 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    101 Nationwide Children's Hospital Columbus Ohio United States 43205
    102 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
    103 Mercy Children's Hospital Toledo Ohio United States 43608
    104 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    105 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
    106 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    107 Oregon Health and Science University Portland Oregon United States 97239
    108 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    109 Geisinger Medical Center Danville Pennsylvania United States 17822
    110 Penn State Children's Hospital Hershey Pennsylvania United States 17033
    111 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    112 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    113 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    114 Medical University of South Carolina Charleston South Carolina United States 29425
    115 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
    116 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    117 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    118 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    119 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    120 Texas Tech University Health Sciences Center-Amarillo Amarillo Texas United States 79106
    121 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    122 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    123 Medical City Dallas Hospital Dallas Texas United States 75230
    124 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    125 Cook Children's Medical Center Fort Worth Texas United States 76104
    126 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    127 Covenant Children's Hospital Lubbock Texas United States 79410
    128 Scott and White Memorial Hospital Temple Texas United States 76508
    129 Primary Children's Hospital Salt Lake City Utah United States 84113
    130 University of Vermont College of Medicine Burlington Vermont United States 05405
    131 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    132 Inova Fairfax Hospital Falls Church Virginia United States 22042
    133 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    134 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    135 Seattle Children's Hospital Seattle Washington United States 98105
    136 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    137 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    138 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    139 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    140 Marshfield Clinic Marshfield Wisconsin United States 54449
    141 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    142 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
    143 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    144 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    145 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    146 Janeway Child Health Centre Saint John's Newfoundland and Labrador Canada A1B 3V6
    147 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
    148 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
    149 Kingston Health Sciences Centre Kingston Ontario Canada K7L 2V7
    150 Children's Hospital London Ontario Canada N6A 5W9
    151 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    152 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    153 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Andrew Olshan, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01119560
    Other Study ID Numbers:
    • AEPI07N1
    • NCI-2011-02257
    • COG-AEPI07N1
    • CDR0000594334
    • AEPI07N1
    • AEPI07N1
    • U10CA180886
    • U10CA098543
    First Posted:
    May 7, 2010
    Last Update Posted:
    Jan 8, 2019
    Last Verified:
    Dec 1, 2018
    Additional relevant MeSH terms:
    Neuroblastoma
    Genetic Predisposition to Disease

    Study Results

    No Results Posted as of Jan 8, 2019