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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01119586
First received: May 6, 2010
Last updated: July 7, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention
Leukemia
Genetic: DNA analysis
Genetic: genetic linkage analysis
Genetic: microarray analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
DNA

Estimated Enrollment: 350
Study Start Date: February 2013
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With High-Risk Acute Lymphoblastic Leukemia
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119586

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Todd E. Druley, MD St. Louis Children's Hospital
  More Information

Additional Information:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01119586     History of Changes
Other Study ID Numbers: AALL10B2  COG-AALL10B2  CDR0000672526  NCI-2011-02232 
Study First Received: May 6, 2010
Last Updated: July 7, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
B-cell adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2016