Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
- Conditions
- SarcomaLeukemiaMyelodysplastic Syndromes
- Interventions
- Genetic: microsatellite instability analysisGenetic: clonality analysisGenetic: mutation analysis
- Registration Number
- NCT00003793
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.
PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.
- Detailed Description
OBJECTIVES:
* Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
* Identify patients who are at increased risk of t-MDS/AML during or after therapy.
OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.
Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 294
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Identification of Genetical suceptibility prior to therapy microsatellite instability analysis Determine the glutathione-s-transferase theta (GSTT1) or glutathione-s-transferase mu (GSTM1) null genotype is more frequent in individuals with t-MDS/AML. Determine the GSTT1 or GSTM1 null genotype is associated with a reduced incidence of relapse of sarcoma. Determine NAT2 or CYP1A1 genotype influences risk of t-MDS/AML. Determine development of a "mutator phenotype" as demonstrated by developing microsatellite instability is an early marker of individuals likely to progress to t-MDS/AML. Increased Risk Of T-MDS/AML before/after Therapy clonality analysis Determine clonal hematopoiesis develops in children receiving high intensity alkylating agent chemotherapy for sarcomas. Determine development of clonal hematopoiesis is associated with increased frequency of t-MDS/AML. Determine measurement of somatic cell mutation frequency, measured by the glycophorin A (GPA) assay prior to and after chemotherapy will predict individuals at increased risk of t-MDS/AML. Identify individuals with ras gene mutations in normal peripheral blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML. Increased Risk Of T-MDS/AML before/after Therapy microsatellite instability analysis Determine clonal hematopoiesis develops in children receiving high intensity alkylating agent chemotherapy for sarcomas. Determine development of clonal hematopoiesis is associated with increased frequency of t-MDS/AML. Determine measurement of somatic cell mutation frequency, measured by the glycophorin A (GPA) assay prior to and after chemotherapy will predict individuals at increased risk of t-MDS/AML. Identify individuals with ras gene mutations in normal peripheral blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML. Identification of Genetical suceptibility prior to therapy mutation analysis Determine the glutathione-s-transferase theta (GSTT1) or glutathione-s-transferase mu (GSTM1) null genotype is more frequent in individuals with t-MDS/AML. Determine the GSTT1 or GSTM1 null genotype is associated with a reduced incidence of relapse of sarcoma. Determine NAT2 or CYP1A1 genotype influences risk of t-MDS/AML. Determine development of a "mutator phenotype" as demonstrated by developing microsatellite instability is an early marker of individuals likely to progress to t-MDS/AML. Increased Risk Of T-MDS/AML before/after Therapy mutation analysis Determine clonal hematopoiesis develops in children receiving high intensity alkylating agent chemotherapy for sarcomas. Determine development of clonal hematopoiesis is associated with increased frequency of t-MDS/AML. Determine measurement of somatic cell mutation frequency, measured by the glycophorin A (GPA) assay prior to and after chemotherapy will predict individuals at increased risk of t-MDS/AML. Identify individuals with ras gene mutations in normal peripheral blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML blood cells after therapy, and whether the identification of such mutations is associated with increased risk of t-MDS/AML.
- Primary Outcome Measures
Name Time Method Event Free Survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (96)
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Tod Children's Hospital - Forum Health
🇺🇸Youngstown, Ohio, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Children's Hospital Central California
🇺🇸Madera, California, United States
Stanford Comprehensive Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
INOVA Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Children's Hospitals and Clinics of Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
🇺🇸Minneapolis, Minnesota, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Maimonides Cancer Center at Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
Office of S. David Lang
🇦🇺Herston, Brisbane, Queensland, Australia
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
🇺🇸Amarillo, Texas, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Ste-Foy, Quebec, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Institute of Oncology at Vilnius University
🇺🇸Portland, Oregon, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
C.S. Mott Children's Hospital at University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States