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Study Of Pharmacogenetic Risk Factors For Avascular Necrosis CCG 1882


N/A
10 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Study Of Pharmacogenetic Risk Factors For Avascular Necrosis CCG 1882


OBJECTIVES:

- Identify possible pharmacogenetic risk factors for avascular necrosis (AVN) in
pediatric patients who received intensive therapy for acute lymphoblastic leukemia on
clinical trial CCG-1882.

- Compare whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D
receptor C/C start site genotype are more common among patients who developed AVN than
among patients who did not.

OUTLINE: This is a retrospective, cohort, multicenter study. Patients are stratified
according to gender and treatment regimen on clinical trial CCG-1882 (augmented vs regular
Berlin-Frankfurt-Munster).

DNA is extracted from slides of blast samples that were previously obtained from patients
treated on clinical trial CCG-1882. DNA genotyping is performed, and genotypes (proportion
of population with variant alleles or frequency of variant alleles) are compared between
patients who did and did not develop avascular necrosis.

PROJECTED ACCRUAL: A total of 671 tissue samples from patients (294 females and 377 males)
will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphoblastic leukemia (ALL)

- Has diagnostic ALL blast sample slides available for DNA extraction

- Previously treated on clinical trial CCG-1882

PATIENT CHARACTERISTICS:

Age

- 10 and over at diagnosis

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Identification of possible pharmacogenetic risk factors for avascular necrosis

Safety Issue:

No

Principal Investigator

Mary Relling, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000304752

NCT ID:

NCT00898469

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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