Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

March 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003291 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia

Official Title ^ICMJE

Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients

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.

Detailed Description

OBJECTIVES:

Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.

OUTLINE: Patients are stratified by risk (standard vs high).

Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Patients are followed for at least 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Genetic: cytogenetic analysis
Genetic: mutation analysis
Other: laboratory biomarker analysis

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, New Zealand, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00003291

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066224, COG-B969, CCG-B969

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Ursula R. Kees, PhD

Telethon Institute for Child Health Research

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP