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
1

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.

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. 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

Outcome Measures

Primary Outcome Measures

  1. Differences in induction outcome, dichotomized into complete remission or no remission [Up to 8 years]

    Assessed with Fisher's exact test.

  2. Differences in induction outcome, dichotomized into complete remission or no remission [Up to 8 years]

    Assessed with Pearson's chi square statistic test

  3. Differences in overall survival [Up to 8 years]

    Evaluated using the log rank statistic.

  4. 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.

  5. 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.

  6. 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.

  7. 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:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Childrens Oncology Group Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01005277
Other Study ID Numbers:
  • ABTR02B1
  • NCI-2009-00325
  • CDR0000271322
  • COG-ABTR02B1
  • ABTR02B1
  • ABTR02B1
  • ABTR02B1
  • U10CA098543
First Posted:
Oct 30, 2009
Last Update Posted:
Jul 14, 2022
Last Verified:
Oct 1, 2017

Study Results

No Results Posted as of Jul 14, 2022