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Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01005277
Enrollment
2000
Registered
2009-10-30
Start date
2002-04-17
Completion date
Unknown
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Promyelocytic Leukemia With PML-RARA, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia, Childhood Acute Myeloid Leukemia in Remission, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia

Brief summary

This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Detailed description

PRIMARY OBJECTIVES: I. Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease. II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered. OUTLINE: Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* DNA samples available from patients meeting the following criteria: * Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) * Patients with pre-B ALL, including responders vs non-responders in selected genotypes \[hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)\] and responders and non-responders regardless of genotype * Pediatric patients with AML registered on POG-9421 * Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML * Pediatric patients with relapsed ALL enrolled on COG-AALL01P2 * Pediatric patients enrolled on COG-9900 and other CCG or POG trials

Design outcomes

Primary

MeasureTime frameDescription
Differences in induction outcome, dichotomized into complete remission or no remissionUp to 8 yearsAssessed with Fisher's exact test.
Differences in overall survivalUp to 8 yearsEvaluated using the log rank statistic.
Disease-free survival (DFS)Time from the end of induction to relapse or death, assessed up to 8 yearsEvaluated using the log rank statistic.
Relapse-free survivalTime from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 yearsEvaluated using the logrank statistic.
Etiology of leukemia: Chi square testUp to 8 yearsChi square test will be used to determine the differences in distribution of genotypes between cases and controls.
Etiology of leukemia: Fisher's exact testUp to 8 yearsFisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026