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Key Adverse Events After Childhood Cancer


N/A
N/A
21 Years
Open (Enrolling)
Both
Cancer Survivor, Cardiovascular Complications, Hematopoietic/Lymphoid Cancer, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Key Adverse Events After Childhood Cancer


PRIMARY OBJECTIVES:

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

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

III. 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.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in
cases and controls, using constitutional DNA and RNA from the cases and controls.

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

OUTLINE: This is a multicenter study.

DNA from peripheral blood or buccal sample of patients is analyzed for the presence of
polymorphisms in candidate genes associated with an increased risk of late-occurring
complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial
infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to
accrual as of 11/26/08), and subsequent malignant neoplasms.

Patients also complete a questionnaire detailing family history and health history.


Inclusion Criteria:



- 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 buccal cell specimen) to the
Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital 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
WBC is > 2,000

- Written informed consent from the patient and/or the patient's legally authorized
guardian, obtained in accordance with institutional policies approved by the U.S.
Department of Health and Human Services

- 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Smita Bhatia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

ALTE03N1

NCT ID:

NCT00082745

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Cancer Survivor
  • Cardiovascular Complications
  • Hematopoietic/Lymphoid Cancer
  • Unspecified Childhood Solid Tumor, Protocol Specific

Name

Location

Baylor College of MedicineHouston, Texas  77030
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Bronson Methodist HospitalKalamazoo, Michigan  49007
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Baptist Hospital of MiamiMiami, Florida  33176-2197
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Scott and White Memorial HospitalTemple, Texas  76508
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Winthrop University HospitalMineola, New York  11501
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
City of Hope Medical CenterDuarte, California  91010
Lehigh Valley Hospital - MuhlenbergBethlehem, Pennsylvania  18017
Lee Memorial Health SystemFort Myers, Florida  33902
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Children's Hospital of AlabamaBirmingham, Alabama  35233
Connecticut Children's Medical CenterHartford, Connecticut  06106
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
University of FloridaGainesville, Florida  32610-0277
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503
Yale UniversityNew Haven, Connecticut  06520
Legacy Emanuel Children's HospitalPortland, Oregon  97227
BI-LO Charities Children's Cancer CenterGreenville, South Carolina  29605
University Of VermontBurlington,, Vermont  05403
University of Texas Southwestern Medical CenterDallas, Texas  
University of KentuckyLexington, Kentucky  40536-0098
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Virginia Commonwealth UniversityRichmond, Virginia  
David Geffen School of Medicine at UCLALos Angeles, California  90095
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
M D Anderson Cancer CenterHouston, Texas  77030
Seattle Children's HospitalSeattle, Washington  98105
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Childrens Memorial HospitalChicago, Illinois  60614
Kaiser Permanente-OaklandOakland, California  94611
University of HawaiiHonolulu, Hawaii  96813
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Saint Vincent Hospital and Health ServicesIndianapolis, Indiana  46260
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Michigan State University - Breslin Cancer CenterEast Lansing, Michigan  48824-1313
Kalamazoo Center for Medical StudiesKalamazoo, Michigan  49008
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Columbia University Medical CenterNew York, New York  10032
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Saint Vincent HospitalGreen Bay, Wisconsin  54301
University of IllinoisChicago, Illinois  60612
Stony Brook University Medical CenterStony Brook, New York  11794
Cook Children's Medical CenterFort Worth, Texas  76104
West Virginia University CharlestonCharleston, West Virginia  25304
The Children's Medical Center of DaytonDayton, Ohio  45404
Advocate Lutheran General HospitalPark Ridge, Illinois  60068
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
Children's Oncology GroupArcadia, California  91006-3776
C S Mott Children's HospitalAnn Arbor, Michigan  48109
University Of Missouri-ColumbiaColumbia, Missouri  65212
Riley Hospital for ChildrenIndianapolis, Indiana  46202
Alfred I duPont Hospital for ChildrenWilmington, Delaware  19803
Nemours Children's Clinic - JacksonvilleJacksonville, Florida  32207-8426
Nemours Childrens Clinic - OrlandoOrlando, Florida  32806
Saint Joseph Children's Hospital of TampaTampa, Florida  33607
Children's Healthcare of Atlanta - EglestonAtlanta, Georgia  30322
The Childrens Mercy HospitalKansas City, Missouri  64108
Rainbow Babies and Childrens HospitalCleveland, Ohio  44106
Palmetto Health RichlandColumbia, South Carolina  29203
East Tennessee Childrens HospitalKnoxville, Tennessee  37916
Saint Joseph's Regional Medical CenterPaterson, New Jersey  07503
Texas Tech University Health Science Center-AmarilloAmarillo, Texas  79106
Childrens Hospital-King's DaughtersNorfolk, Virginia  23507
Sanford Medical Center-FargoFargo, North Dakota  58122
Children's Hospital ColoradoAurora, Colorado  80045
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, California  94304
Greenville Cancer Treatment CenterGreenville, South Carolina  29605
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
Carilion Clinic Children's HospitalRoanoke, Virginia  24014
Providence Sacred Heart Medical Center and Children's HospitalSpokane, Washington  99204
Mattel Children's Hospital UCLALos Angeles, California  90095
Georgia Regents UniversityAugusta, Georgia  30912