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NCT01119586 Clinical Trial

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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01119586
Other study ID # AALL10B2
Secondary ID COG-AALL10B2CDR0
Status Completed
Phase N/A
First received May 6, 2010
Last updated July 7, 2016
Start date February 2013

Study information
Verified date July 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 30 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• genetic linkage analysis

• microarray analysis

• nucleic acid sequencing

• polymerase chain reaction

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis No
Primary 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 No
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