Clinical trial NCT00898469: Identifying Risk Factors for Bone Tissue Death in Young Patients With Acute Lymphoblastic Leukemia Treated on Clinical Trial CCG-1882
Official title: Study Of Pharmacogenetic Risk Factors For Avascular Necrosis CCG 1882
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 671
Sex: ALL
Minimum age (years): 10
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who received intensive therapy for acute lymphoblastic leukemia on clinical trial CCG-1882.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to bone tissue death.

PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Identification of possible pharmacogenetic risk factors for avascular necrosis
timeFrame: length of study
measure: Comparison of whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D receptor C/C start site genotype are more common among patients who developed avascular necrosis than among patients who did not
timeFrame: length of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Mary Relling, PharmD
role: STUDY_CHAIR
References:
citation: Hamilton LH, Mattano LA, Sather HN, et al.: A SERPINE1 (PAI-1) single nucleotide polymorphism predicts osteonecrosis in children treated for acute lymphoblastic leukemia: results of the Childrens Oncology Group (COG) study AALL03B2. [Abstract] Blood 108 (11): A-709, 2006.