NCT00003291

Brief Summary

RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia. PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

8 years

First QC Date

November 1, 1999

Last Update Submit

August 7, 2014

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia

Interventions

cytogenetic analysisGENETIC
mutation analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
DISEASE CHARACTERISTICS: * Newly diagnosed acute lymphoblastic leukemia (ALL) * Meets criteria for 1 of the following: * Standard risk, as defined by the following: * 1 to 10 years old at diagnosis * WBC less than 50,000/mm\^3 * High risk, as defined by the following: * Less than 1 year old or over 10 years old at diagnosis * WBC greater than 50,000/mm\^3 * Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL) PATIENT CHARACTERISTICS: Age: * See Disease Characteristics Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

MeSH Terms

Conditions

Leukemia

Interventions

Cytogenetic Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic Techniques

Study Officials

  • Ursula R. Kees, PhD

    Telethon Institute for Child Health Research

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1998

Primary Completion

March 1, 2006

Last Updated

August 8, 2014

Record last verified: 2014-08

Locations

AU(1)