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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003291 |
RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.
PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.
Condition | Intervention |
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Leukemia |
Procedure: cytogenetic analysis Procedure: laboratory biomarker analysis Procedure: mutation analysis |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients |
Estimated Enrollment: | 200 |
Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: Patients are stratified by risk (standard vs high).
Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Patients are followed for at least 3 years.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets criteria for 1 of the following:
Standard risk, as defined by the following:
High risk, as defined by the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Ursula R. Kees, PhD | Telethon Institute for Child Health Research |
Study ID Numbers: | CDR0000066224, COG-B969, CCG-B969 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003291 |
Health Authority: | United States: Federal Government |
untreated childhood acute lymphoblastic leukemia |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |