Clinical trial NCT01119586: Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
Official title: Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: B-cell adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-07
Enrollment: 350
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With High-Risk Acute Lymphoblastic Leukemia

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

PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
* To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
* To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
* To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.

OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia

  * Matched patients non-tumor and blast DNA samples
  * Enrolled on COG-P9906 or COG-AALL0232 protocols
* Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri

PATIENT CHARACTERISTICS:

* Newborn infants from the state of Missouri

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis
measure: Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis Children's Hospital
name: Todd E. Druley, MD
role: PRINCIPAL_INVESTIGATOR
References: