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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT00082745

Studienbeginn:
März 2004

Letztes Update:
24.08.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Children's Oncology Group

Collaborator:
National Cancer Institute (NCI)

Studienleiter

Smita Bhatia
Principal Investigator
Children's Oncology Group

Studienlocations (3 von 156)

University of Alabama at Birmingham Cancer Center
35233 Birmingham
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Arkansas for Medical Sciences
72205 Little Rock
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente Downey Medical Center
90242 Downey
United StatesSchwebend» Google-Maps
Children's Hospital and Research Center at Oakland
94609-1809 Oakland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 510-428-3324
E-Mail: cgolden@mail.cho.org
» Ansprechpartner anzeigen
Lucile Packard Children's Hospital Stanford University
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-694-0012
E-Mail: ccto-office@stanford.edu
» Ansprechpartner anzeigen
Children's Hospital Colorado
80045 Aurora
United StatesSchwebend» Google-Maps
Lee Memorial Health System
33901 Fort Myers
United StatesAktiv, nicht rekrutierend» Google-Maps
Golisano Children's Hospital of Southwest Florida
33908 Fort Myers
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 239-343-5333
E-Mail: molly.arnstrom@leehealth.org
» Ansprechpartner anzeigen
University of Florida Health Science Center - Gainesville
32610 Gainesville
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Miami Miller School of Medicine-Sylvester Cancer Center
33136 Miami
United StatesAktiv, nicht rekrutierend» Google-Maps
Nicklaus Children's Hospital
33155 Miami
United StatesSchwebend» Google-Maps
Nemours Children's Clinic - Orlando
32806 Orlando
United StatesAktiv, nicht rekrutierend» Google-Maps
Nemours Children's Clinic - Pensacola
32504 Pensacola
United StatesAktiv, nicht rekrutierend» Google-Maps
Johns Hopkins All Children's Hospital
33701 Saint Petersburg
United StatesSchwebend» Google-Maps
Saint Joseph's Hospital/Children's Hospital-Tampa
33607 Tampa
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 813-356-7168
E-Mail: Katelynn.Colgain@baycare.org
» Ansprechpartner anzeigen
University of Hawaii Cancer Center
96813 Honolulu
United StatesAktiv, nicht rekrutierend» Google-Maps
Lurie Children's Hospital-Chicago
60611 Chicago
United StatesSchwebend» Google-Maps
University of Chicago Comprehensive Cancer Center
60637 Chicago
United StatesSchwebend» Google-Maps
Advocate Children's Hospital-Oak Lawn
60453 Oak Lawn
United StatesSchwebend» Google-Maps
Advocate Lutheran General Hospital
60068 Park Ridge
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Vincent Hospital and Health Care Center
46260 Indianapolis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 317-338-2194
E-Mail: research@stvincent.org
» Ansprechpartner anzeigen
University of Kansas Cancer Center
66160 Kansas City
United StatesAktiv, nicht rekrutierend» Google-Maps
Tulane University Health Sciences Center
70112 New Orleans
United StatesSchwebend» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
Wayne State University/Karmanos Cancer Institute
48201 Detroit
United StatesAktiv, nicht rekrutierend» Google-Maps
Michigan State University Clinical Center
48824-7016 East Lansing
United StatesSchwebend» Google-Maps
Hurley Medical Center
48503 Flint
United StatesAktiv, nicht rekrutierend» Google-Maps
Helen DeVos Children's Hospital at Spectrum Health
49503 Grand Rapids
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 616-391-1230
E-Mail: crcwm-regulatory@crcwm.org
» Ansprechpartner anzeigen
Kalamazoo Center for Medical Studies
49008 Kalamazoo
United StatesAktiv, nicht rekrutierend» Google-Maps
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
89135 Las Vegas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 702-384-0013
E-Mail: research@sncrf.org
» Ansprechpartner anzeigen
Saint Barnabas Medical Center
07039 Livingston
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Peter's University Hospital
08901 New Brunswick
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 732-745-8600
Phone (ext.): 6163
E-Mail: kcovert@saintpetersuh.com
» Ansprechpartner anzeigen
Newark Beth Israel Medical Center
07112 Newark
United StatesSchwebend» Google-Maps
University of New Mexico Cancer Center
87102 Albuquerque
United StatesSchwebend» Google-Maps
Brooklyn Hospital Center
11201 Brooklyn
United StatesAktiv, nicht rekrutierend» Google-Maps
Maimonides Medical Center
11219 Brooklyn
United StatesAktiv, nicht rekrutierend» Google-Maps
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
10032 New York
United StatesSchwebend» Google-Maps
Stony Brook University Medical Center
11794 Stony Brook
United StatesSchwebend» Google-Maps
New York Medical College
10595 Valhalla
United StatesSchwebend» Google-Maps
UNC Lineberger Comprehensive Cancer Center
27599 Chapel Hill
United StatesSchwebend» Google-Maps
Sanford Broadway Medical Center
58122 Fargo
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 701-323-5760
E-Mail: OncologyClinicalTrialsFargo@sanfordhealth.org
» Ansprechpartner anzeigen
Children's Hospital Medical Center of Akron
44308 Akron
United StatesSchwebend» Google-Maps
Rainbow Babies and Childrens Hospital
44106 Cleveland
United StatesSchwebend» Google-Maps
University of Oklahoma Health Sciences Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 405-271-8777
E-Mail: ou-clinical-trials@ouhsc.edu
» Ansprechpartner anzeigen
Legacy Emanuel Hospital and Health Center
97227 Portland
United StatesAktiv, nicht rekrutierend» Google-Maps
Lehigh Valley Hospital - Muhlenberg
18017 Bethlehem
United StatesAktiv, nicht rekrutierend» Google-Maps
Children's Hospital of Philadelphia
19104 Philadelphia
United StatesSchwebend» Google-Maps
BI-LO Charities Children's Cancer Center
29605 Greenville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 864-522-2066
E-Mail: kim.williams3@prismahealth.org
» Ansprechpartner anzeigen
Greenville Cancer Treatment Center
29605 Greenville
United StatesAktiv, nicht rekrutierend» Google-Maps
Sanford USD Medical Center - Sioux Falls
57117-5134 Sioux Falls
United StatesSchwebend» Google-Maps
East Tennessee State University
37614-0054 Johnson City
United StatesAktiv, nicht rekrutierend» Google-Maps
East Tennessee Childrens Hospital
37916 Knoxville
United StatesSchwebend» Google-Maps
Texas Tech University Health Sciences Center-Amarillo
79106 Amarillo
United StatesAktiv, nicht rekrutierend» Google-Maps
UT Southwestern/Simmons Cancer Center-Dallas
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 214-648-7097
E-Mail: canceranswerline@UTSouthwestern.edu
» Ansprechpartner anzeigen
Cook Children's Medical Center
76104 Fort Worth
United StatesSchwebend» Google-Maps
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 713-798-1354
E-Mail: burton@bcm.edu
» Ansprechpartner anzeigen
M D Anderson Cancer Center
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Children's Hospital of San Antonio
78207 San Antonio
United StatesSchwebend» Google-Maps
Methodist Children's Hospital of South Texas
78229 San Antonio
United StatesSchwebend» Google-Maps
University of Texas Health Science Center at San Antonio
78229 San Antonio
United StatesAktiv, nicht rekrutierend» Google-Maps
Primary Children's Hospital
84113 Salt Lake City
United StatesSchwebend» Google-Maps
Inova Fairfax Hospital
22042 Falls Church
United StatesSchwebend» Google-Maps
Virginia Commonwealth University/Massey Cancer Center
23298 Richmond
United StatesSchwebend» Google-Maps
Seattle Children's Hospital
98105 Seattle
United StatesSchwebend» Google-Maps
Providence Sacred Heart Medical Center and Children's Hospital
99204 Spokane
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 800-228-6618
E-Mail: HopeBeginsHere@providence.org
» Ansprechpartner anzeigen
West Virginia University Charleston Division
25304 Charleston
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Vincent Hospital Cancer Center Green Bay
54301 Green Bay
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: 920-433-8889
E-Mail: Christy.Gilchrist@hshs.org
» Ansprechpartner anzeigen
Royal Brisbane and Women's Hospital
4029 Herston
AustraliaAktiv, nicht rekrutierend» Google-Maps
Royal Children's Hospital-Brisbane
4029 Herston
AustraliaAktiv, nicht rekrutierend» Google-Maps
Women's and Children's Hospital-Adelaide
5006 North Adelaide
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Site Public Contact
Phone: (08) 8161 7327
E-Mail: cywhs.oncsec@health.sa.gov.au
» Ansprechpartner anzeigen
Princess Margaret Hospital for Children
6008 Perth
AustraliaAktiv, nicht rekrutierend» Google-Maps
British Columbia Children's Hospital
V6H 3V4 Vancouver
CanadaSchwebend» Google-Maps
The Montreal Children's Hospital of the MUHC
H3H 1P3 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Allan Blair Cancer Centre
S4T 7T1 Regina
CanadaAktiv, nicht rekrutierend» Google-Maps
San Jorge Children's Hospital
00912 San Juan
Puerto RicoSchwebend» Google-Maps
Swiss Pediatric Oncology Group - Geneva
1205 Geneva
SwitzerlandSchwebend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

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 deoxyribonucleic acid (DNA) and ribonucleic acid (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:

DNA and RNA 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.

Ein-/Ausschlusskriterien

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 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 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

- Myocardial infarction (MI)

- Ischemic stroke (IS)

- Avascular necrosis (AVN)

- Subsequent malignant neoplasm (SMN)

- CONTROLS: 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

- 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

Studien-Rationale

Primary outcome:

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

Geprüfte Regime

  • Laboratory Biomarker Analysis:
    Correlative studies
  • Questionnaire Administration:
    Ancillary studies

Quelle: ClinicalTrials.gov


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