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OpenTrials
Completed

NCT Number: NCT00003291

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cytogenetic analysis

Genetic

mutation analysis

Genetic

laboratory biomarker analysis

Other

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients

Important dates

Study start
1998
Primary completion
2006
First posted
Jan 27, 2003
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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