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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00664131 |
Treatment of acute lymphoblastic leukemia achieves high cure rate, but is potentially neurotoxic.
Long-term neurologic morbidity in survivors and its effect on function are inadequately studied.
Neurologic outcomes will be assessed through an investigator administered questionnaire followed by comprehensive neurologic examination by the study neurologist.
Condition | Intervention |
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Acute Lymphoblastic Leukemia |
Other: Neurological Examination/Questionnaires |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors |
Estimated Enrollment: | 1000 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 |
Other: Neurological Examination/Questionnaires
See Detailed Description section for description of treatment plan.
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Acute lymphoblastic leukemia (ALL) is the most prevalent childhood malignant disease. Survival has improved from 5-10% in the early 1960s to over 80% at present. Historically, the central nervous system (CNS) was the most common site of leukemia relapse. However, major improvement in cure rates was achieved with the addition of CNS directed therapy using initially craniospinal irradiation, and more recently, a combination of high-dose systemic methotrexate and intrathecal chemotherapy.
ALL mostly afflicts children in the first 12-years of life, an age when progressive myelination is taking place and the central nervous system is more vulnerable to chemical and radiologic injury. Many ALL studies have reported neurologic adverse events related to the treatment.
Little is known about the long-term outcome of neurologic toxicity developing during treatment of leukemia, or development of new late onset neurologic complications. No data is available about outcomes of non-behavioral/cognitive neurologic complications, such as seizures, incoordination, headache, loss of motor or sensory function, impaired energy and muscle weakness. In addition, there is no data available on impact of neurologic disability on quality of life of ALL survivors.
It is important to understand and recognize neurologic disability, its causes and impact on function and quality of life so that adequate and timely remedies can be offered through education and appropriate interventions can be undertaken to help prevent long-term morbidity.
This is a prospective observational study of ALL St. Jude Children's Research Hospital survivors to determine the prevalence of different headache syndromes, as defined by International Society of Headache criteria (IHS) and the prevalence and severity of seizures and their relationship to leukemia treatment. We will establish incidence, type, severity, and disability of sensory-motor neuropathy when present or any long term progression of initial peripheral nerve injury in ALL survivors. This study will also help define whether there is a higher incidence of low back pain and if there is any relation to a specific treatment.
Subjects will have a one-time evaluation with an investigator administered questionnaire and a neurologic examination.
Ages Eligible for Study: | 6 Years to 28 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Survivors of ALL who are currently 6-28 years of age, 5 years from ALL diagnosis, and 1 year off therapy who were treated on institutional protocols at St. Jude Children's Research Hospital. Survivors will be recruited in the Leukemia and ACT clinics at St. Jude Children's Research Hospital. We anticipate that 494 survivors are available. We plan to enroll every survivor who is eligible and visits Leukemia or/ and ACT clinic at St. Jude Children's Research Hospital
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 |
Principal Investigator: | Brannon Morris, MD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Brannon Morris, MD ) |
Study ID Numbers: | ALLNOQ |
Study First Received: | April 21, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00664131 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute Lymphoblastic Leukemia ALL survivors ALL neurologic symptoms ALL neurologic disability ALL late effects |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders |
Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Lymphoproliferative Disorders |