Clinical and Biological Predictors of Therapy-Related Leukemia
Genetic Data
+ genetic Data
+ genetic Data
Collected from today forward - ProspectiveBone Marrow Diseases+18
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: December 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.294 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnosis of sarcoma including: Rhabdomyosarcoma Ewing's sarcoma Primitive neuroectodermal tumor Fibrosarcoma Malignant peripheral nerve sheath tumor Synovial cell sarcoma Osteosarcoma Other soft tissue sarcoma Must be currently receiving intensive or high-dose chemotherapy for sarcoma PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 96 locations
Southern California Permanente Medical Group
Downey, United StatesOpen Southern California Permanente Medical Group in Google MapsJonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, United StatesJonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesChildren's Hospital Central California
Madera, United States