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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00082745
Other study ID # ALTE03N1
Secondary ID COG-ALTE03N1CDR0
Status Recruiting
Phase
First received
Last updated
Start date March 25, 2004

Study information

Verified date April 2024
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Other known NCT identifiers
  • NCT00228787

Recruitment information / eligibility

Status Recruiting
Enrollment 3885
Est. completion date
Est. primary completion date December 31, 2004
Accepts healthy volunteers No
Gender All
Age group N/A to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Royal Children's Hospital-Brisbane Herston Queensland
Australia Women's and Children's Hospital-Adelaide North Adelaide South Australia
Australia Royal Children's Hospital Parkville Victoria
Australia Perth Children's Hospital Perth Western Australia
Australia Princess Margaret Hospital for Children Perth Western Australia
Australia Queensland Children's Hospital South Brisbane Queensland
Canada University of Alberta Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada Children's Hospital London Ontario
Canada Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec
Canada The Montreal Children's Hospital of the MUHC Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Puerto Rico San Jorge Children's Hospital San Juan
Switzerland Swiss Pediatric Oncology Group - Geneva Geneva
United States Children's Hospital Medical Center of Akron Akron Ohio
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Texas Tech University Health Sciences Center-Amarillo Amarillo Texas
United States C S Mott Children's Hospital Ann Arbor Michigan
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Eastern Maine Medical Center Bangor Maine
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Children's Hospital of Alabama Birmingham Alabama
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Brooklyn Hospital Center Brooklyn New York
United States Maimonides Medical Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States University of Vermont and State Agricultural College Burlington Vermont
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Lurie Children's Hospital-Chicago Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Rainbow Babies and Childrens Hospital Cleveland Ohio
United States Columbia Regional Columbia Missouri
United States Prisma Health Richland Hospital Columbia South Carolina
United States Nationwide Children's Hospital Columbus Ohio
United States Driscoll Children's Hospital Corpus Christi Texas
United States Medical City Dallas Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Dayton Children's Hospital Dayton Ohio
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Kaiser Permanente Downey Medical Center Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Michigan State University Clinical Center East Lansing Michigan
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Broadway Medical Center Fargo North Dakota
United States Hurley Medical Center Flint Michigan
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Lee Memorial Health System Fort Myers Florida
United States Cook Children's Medical Center Fort Worth Texas
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States Greenville Cancer Treatment Center Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic-Jacksonville Jacksonville Florida
United States East Tennessee State University Johnson City Tennessee
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Kalamazoo Center for Medical Studies Kalamazoo Michigan
United States Children's Mercy Hospitals and Clinics Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Arkansas Children's Hospital Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Barnabas Medical Center Livingston New Jersey
United States Cedars Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States Mattel Children's Hospital UCLA Los Angeles California
United States Norton Children's Hospital Louisville Kentucky
United States Valley Children's Hospital Madera California
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Miami Cancer Institute Miami Florida
United States Nicklaus Children's Hospital Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Children's Hospital New Orleans New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois
United States Children's Hospital and Research Center at Oakland Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nemours Children's Clinic - Orlando Orlando Florida
United States Nemours Children's Hospital Orlando Florida
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Advocate Children's Hospital-Park Ridge Park Ridge Illinois
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Legacy Emanuel Children's Hospital Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Carilion Clinic Children's Hospital Roanoke Virginia
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Primary Children's Hospital Salt Lake City Utah
United States Children's Hospital of San Antonio San Antonio Texas
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Rady Children's Hospital - San Diego San Diego California
United States Seattle Children's Hospital Seattle Washington
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington
United States Stony Brook University Medical Center Stony Brook New York
United States State University of New York Upstate Medical University Syracuse New York
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States New York Medical College Valhalla New York
United States Children's National Medical Center Washington District of Columbia
United States Alfred I duPont Hospital for Children Wilmington Delaware
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Puerto Rico,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control) 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. Up to 1 year
Primary Frequency of mutations or polymorphisms in specific candidate genes in cases and controls 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. Up to 1 year
Primary Crude disease-exposure 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. Up to 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT00772200 - Neuropsychological and Behavioral Testing in Younger Patients With Cancer