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OpenTrials
Completed

NCT Number: NCT01119586

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

1 year–30 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DNA analysis

Genetic

genetic linkage analysis

Genetic

microarray analysis

Genetic

nucleic acid sequencing

Genetic

polymerase chain reaction

Genetic

polymorphism analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis

  2. 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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
First posted
May 7, 2010
Registry last updated
Jul 11, 2016

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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