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Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT00082745
Collaborator
National Cancer Institute (NCI) (NIH)
3,885
Enrollment
156
Locations
24.9
Patients Per Site

Study Details

Study Description

Brief Summary

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Condition or Disease Intervention/Treatment Phase
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

  1. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

  2. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

  3. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

  4. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.

  5. To explore the role and nature of gene-environment interaction in the development of key adverse events.

OUTLINE:

DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3885 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Key Adverse Events After Childhood Cancer
Actual Study Start Date :
Mar 22, 2004
Actual Primary Completion Date :
Dec 31, 2004

Arms and Interventions

Arm Intervention/Treatment
Observational (genetic analysis)

DNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control) [Up to 1 year]

    Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar's test for paired data will be used to compare the unmatched general characteristics of cases and controls.

  2. Frequency of mutations or polymorphisms in specific candidate genes in cases and controls [Up to 1 year]

    Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.

  3. Crude disease-exposure [Up to 1 year]

    The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • ELIGIBILITY CRITERIA - CASES

  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age

  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant

  • Development of one of the following key adverse events at any time following initiation of cancer therapy:

  • Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual

  • Ischemic stroke (IS)

  • Subsequent malignant neoplasm (SMN)

  • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual

  • Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center at the University of Alabama at Birmingham as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000

  • Written informed consent from the patient and/or the patient's legally authorized guardian

  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required

  • ELIGIBILITY CRITERIA - CONTROLS

  • CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age

  • CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant

  • CONTROLS: No clinical evidence of any of the following key adverse events:

  • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000

  • Ischemic stroke (IS)

  • Avascular necrosis (AVN)

  • Subsequent malignant neoplasm (SMN)

  • CONTROLS: Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center Laboratory at the University of Alabama at Birmingham as per the requirements

  • CONTROLS: Written informed consent from the patient and/or the patient's legally authorized guardian

  • CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Alabama Birmingham Alabama United States 35233
2 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
3 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
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 City of Hope Comprehensive Cancer Center Duarte California United States 91010
7 Children's Hospital Los Angeles Los Angeles California United States 90027
8 Cedars Sinai Medical Center Los Angeles California United States 90048
9 Mattel Children's Hospital UCLA Los Angeles California United States 90095
10 Valley Children's Hospital Madera California United States 93636
11 Children's Hospital and Research Center at Oakland Oakland California United States 94609-1809
12 Kaiser Permanente-Oakland Oakland California United States 94611
13 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
14 Rady Children's Hospital - San Diego San Diego California United States 92123
15 Children's Hospital Colorado Aurora Colorado United States 80045
16 Connecticut Children's Medical Center Hartford Connecticut United States 06106
17 Yale University New Haven Connecticut United States 06520
18 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
19 Children's National Medical Center Washington District of Columbia United States 20010
20 Lee Memorial Health System Fort Myers Florida United States 33901
21 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
22 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
23 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
24 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
25 Nicklaus Children's Hospital Miami Florida United States 33155
26 Miami Cancer Institute Miami Florida United States 33176
27 Nemours Children's Clinic - Orlando Orlando Florida United States 32806
28 Nemours Children's Hospital Orlando Florida United States 32827
29 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
30 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
31 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
32 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
33 Augusta University Medical Center Augusta Georgia United States 30912
34 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
35 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
36 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
37 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
38 University of Illinois Chicago Illinois United States 60612
39 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
40 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
41 Advocate Children's Hospital-Park Ridge Park Ridge Illinois United States 60068
42 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
43 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
44 Riley Hospital for Children Indianapolis Indiana United States 46202
45 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
46 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
47 University of Kansas Cancer Center Kansas City Kansas United States 66160
48 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
49 Norton Children's Hospital Louisville Kentucky United States 40202
50 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
51 Children's Hospital New Orleans New Orleans Louisiana United States 70118
52 Eastern Maine Medical Center Bangor Maine United States 04401
53 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
54 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
55 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
56 Ascension Saint John Hospital Detroit Michigan United States 48236
57 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
58 Hurley Medical Center Flint Michigan United States 48503
59 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
60 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
61 Kalamazoo Center for Medical Studies Kalamazoo Michigan United States 49008
62 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
63 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
64 Mayo Clinic Rochester Minnesota United States 55905
65 University of Mississippi Medical Center Jackson Mississippi United States 39216
66 Columbia Regional Columbia Missouri United States 65201
67 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
68 Washington University School of Medicine Saint Louis Missouri United States 63110
69 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
70 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
71 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
72 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
73 Hackensack University Medical Center Hackensack New Jersey United States 07601
74 Saint Barnabas Medical Center Livingston New Jersey United States 07039
75 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
76 Newark Beth Israel Medical Center Newark New Jersey United States 07112
77 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
78 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
79 Brooklyn Hospital Center Brooklyn New York United States 11201
80 Maimonides Medical Center Brooklyn New York United States 11219
81 Roswell Park Cancer Institute Buffalo New York United States 14263
82 NYU Winthrop Hospital Mineola New York United States 11501
83 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
84 Memorial Sloan Kettering Cancer Center New York New York United States 10065
85 Stony Brook University Medical Center Stony Brook New York United States 11794
86 State University of New York Upstate Medical University Syracuse New York United States 13210
87 New York Medical College Valhalla New York United States 10595
88 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
89 Duke University Medical Center Durham North Carolina United States 27710
90 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
91 Sanford Broadway Medical Center Fargo North Dakota United States 58122
92 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
93 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
94 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
95 Nationwide Children's Hospital Columbus Ohio United States 43205
96 Dayton Children's Hospital Dayton Ohio United States 45404
97 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
98 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
99 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
100 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
101 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
102 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
103 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
104 Prisma Health Richland Hospital Columbia South Carolina United States 29203
105 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
106 Greenville Cancer Treatment Center Greenville South Carolina United States 29605
107 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
108 East Tennessee State University Johnson City Tennessee United States 37614-0054
109 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
110 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
111 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
112 Texas Tech University Health Sciences Center-Amarillo Amarillo Texas United States 79106
113 Driscoll Children's Hospital Corpus Christi Texas United States 78411
114 Medical City Dallas Hospital Dallas Texas United States 75230
115 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
116 Cook Children's Medical Center Fort Worth Texas United States 76104
117 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
118 M D Anderson Cancer Center Houston Texas United States 77030
119 Children's Hospital of San Antonio San Antonio Texas United States 78207
120 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
121 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
122 Scott and White Memorial Hospital Temple Texas United States 76508
123 Primary Children's Hospital Salt Lake City Utah United States 84113
124 University of Vermont and State Agricultural College Burlington Vermont United States 05405
125 Inova Fairfax Hospital Falls Church Virginia United States 22042
126 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
127 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
128 Carilion Clinic Children's Hospital Roanoke Virginia United States 24014
129 Seattle Children's Hospital Seattle Washington United States 98105
130 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
131 West Virginia University Charleston Division Charleston West Virginia United States 25304
132 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
133 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
134 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
135 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
136 Royal Children's Hospital-Brisbane Herston Queensland Australia 4029
137 Queensland Children's Hospital South Brisbane Queensland Australia 4101
138 Women's and Children's Hospital-Adelaide North Adelaide South Australia Australia 5006
139 Royal Children's Hospital Parkville Victoria Australia 3052
140 Princess Margaret Hospital for Children Perth Western Australia Australia 6008
141 Perth Children's Hospital Perth Western Australia Australia 6009
142 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
143 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
144 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
145 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
146 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
147 Kingston Health Sciences Centre Kingston Ontario Canada K7L 2V7
148 Children's Hospital London Ontario Canada N6A 5W9
149 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
150 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
151 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H3H 1P3
152 Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec Canada H3T 1C5
153 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
154 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
155 San Jorge Children's Hospital San Juan Puerto Rico 00912
156 Swiss Pediatric Oncology Group - Geneva Geneva Switzerland 1205

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Smita Bhatia, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00082745
Other Study ID Numbers:
  • ALTE03N1
  • NCI-2011-03822
  • COG-ALTE03N1
  • CDR0000360708
  • ALTE03N1
  • ALTE03N1
  • U10CA180886
  • U10CA095861
  • UG1CA189955
  • UG1CA189958
  • NCT00228787
First Posted:
May 19, 2004
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Aug 5, 2021