Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia

Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01119586

Enrollment

350

Registered

2010-05-07

Start date

2013-02-28

Completion date

Unknown

Last updated

2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

GENETICDNA analysis

GENETICgenetic linkage analysis

GENETICmicroarray analysis

GENETICnucleic acid sequencing

GENETICpolymerase chain reaction

GENETICpolymorphism analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 30 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis	—
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026