NCT01005277

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2002

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
Last Updated

July 14, 2022

Status Verified

October 1, 2017

Enrollment Period

14.1 years

First QC Date

October 29, 2009

Last Update Submit

July 12, 2022

Conditions

Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1Adult Acute Promyelocytic Leukemia With PML-RARAChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid LeukemiaChildhood Acute Myeloid Leukemia in RemissionRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (7)

  • Differences in induction outcome, dichotomized into complete remission or no remission

    Assessed with Fisher's exact test.

    Up to 8 years

  • Differences in induction outcome, dichotomized into complete remission or no remission

    Assessed with Pearson's chi square statistic test

    Up to 8 years

  • Differences in overall survival

    Evaluated using the log rank statistic.

    Up to 8 years

  • Disease-free survival (DFS)

    Evaluated using the log rank statistic.

    Time from the end of induction to relapse or death, assessed up to 8 years

  • Relapse-free survival

    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

    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

    Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.

    Up to 8 years

Study Arms (1)

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

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative (genetic polymorphisms)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, AcuteLeukemia, Promyelocytic, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid, AcuteLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Stella Davies

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

April 17, 2002

Primary Completion

May 5, 2016

Last Updated

July 14, 2022

Record last verified: 2017-10

Locations

US(1)