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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01005277

Collaborator

National Cancer Institute (NCI) (NIH)

2,000

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Laboratory Biomarker Analysis

Detailed Description

PRIMARY OBJECTIVES:

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.
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

Actual Study Start Date :

Apr 17, 2002

Actual Primary Completion Date :

May 5, 2016

Arms and Interventions

Arm	Intervention/Treatment
Ancillary-Correlative (genetic polymorphisms) 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.	Other: Laboratory Biomarker Analysis Correlative studies

Arm

Intervention/Treatment

Ancillary-Correlative (genetic polymorphisms)

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.

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Differences in induction outcome, dichotomized into complete remission or no remission [Up to 8 years]
Assessed with Fisher's exact test.
Differences in induction outcome, dichotomized into complete remission or no remission [Up to 8 years]
Assessed with Pearson's chi square statistic test
Differences in overall survival [Up to 8 years]
Evaluated using the log rank statistic.
Disease-free survival (DFS) [Time from the end of induction to relapse or death, assessed up to 8 years]
Evaluated using the log rank statistic.
Relapse-free survival [Time from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 years]
Evaluated using the logrank statistic.
Etiology of leukemia: Chi square test [Up to 8 years]
Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.
Etiology of leukemia: Fisher's exact test [Up to 8 years]
Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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