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

July 12, 2022 updated by: Children's Oncology Group

Genetic Polymorphisms in ALL Samples Submitted to Gene Array Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stella Davies, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 17, 2002

Primary Completion (ACTUAL)

May 5, 2016

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (ESTIMATE)

October 30, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABTR02B1 (OTHER: CTEP)
  • U10CA098543 (U.S. NIH Grant/Contract)
  • NCI-2009-00325 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CDR0000271322
  • COG-ABTR02B1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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