ClinicalTrials.gg
CompletedNCT00003933Updated Aug 7, 2014

Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia

An interventional study of laboratory biomarker analysis in Leukemia, sponsored by Children's Oncology Group. Completed at 41 sites in 3 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2014-08-07.

Sponsored by Children's Oncology Group · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Ages
Up to 17 Years
Sex
All
01

Study summary

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941.
  • Determine the prognostic importance of p16/p15 abnormalities in these children.
  • Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients.

OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15.

PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.

02

Conditions studied

  • Leukemia

Keywords

  • recurrent childhood acute lymphoblastic leukemia
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 447 studies on the registry; 35 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphocytic leukemia and treated on protocol CCG-1941
  • Material cryopreserved in the CCG cell bank

PATIENT CHARACTERISTICS:

Age:

  • Children

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • See Disease Characteristics
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic

Interventions

  • Otherlaboratory biomarker analysis
06

Study locations

41 sites
  • Long Beach Memorial Medical Center
    Long Beach, California 90806, United States
  • Children's Hospital Los Angeles
    Los Angeles, California 90027-0700, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • UCSF Cancer Center and Cancer Research Institute
    San Francisco, California 94143-0128, United States
  • David Grant Medical Center
    Travis Air Force Base, California 94535, United States
  • Children's Hospital of Denver
    Denver, Colorado 80218, United States
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010-2970, United States
  • Shands Hospital and Clinics, University of Florida
    Gainesville, Florida 32610-100277, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242-1009, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0752, United States
  • CCOP - Kalamazoo
    Kalamazoo, Michigan 49007-3731, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-3330, United States
  • Saint Peter's University Hospital
    New Brunswick, New Jersey 08901-1780, United States
  • Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
    New York, New York 10016, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina 27599-7295, United States
  • Veterans Affairs Medical Center - Fargo
    Fargo, North Dakota 58102, United States
  • CCOP - Merit Care Hospital
    Fargo, North Dakota 58122, United States
  • Children's Hospital Medical Center - Cincinnati
    Cincinnati, Ohio 45229-3039, United States
  • Ireland Cancer Center
    Cleveland, Ohio 44106-5065, United States
  • Children's Hospital of Columbus
    Columbus, Ohio 43205-2696, United States
  • Doernbecher Children's Hospital
    Portland, Oregon 97201-3098, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
  • University of Texas - MD Anderson Cancer Center
    Houston, Texas 77030-4009, United States
  • Children's Hospital and Regional Medical Center - Seattle
    Seattle, Washington 98105, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
  • University of Wisconsin Comprehensive Cancer Center
    Madison, Wisconsin 53792-6164, United States
  • Princess Margaret Hospital for Children
    Perth, Western Australia 6001, Australia
  • British Columbia Children's Hospital
    Vancouver, British Columbia V6H 3V4, Canada
  • IWK Health Centre
    Halifax, Nova Scotia B3J 3G9, Canada
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 1999 and a primary completion of Apr 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 1999
First posted
May 2, 2003
Start
Apr 1999
Primary completionActual
Apr 2006
Last update
Aug 7, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00003933
Responsible party
Sponsor
First posted
May 2, 2003
Start date
Apr 1999
Primary completion
Apr 2006
Last update
Aug 7, 2014

Study contacts

Stephen P. Hunger, MD
study chair · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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