History of Changes for Study: NCT01119586


Unique Protocol ID:	AALL10B2
Brief Title:	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
Secondary IDs:	COG-AALL10B2 [Children’s Oncology Group] CDR0000672526 [Clinicaltrials.gov] NCI-2011-02232 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]

Study Status


Record Verification:	July 2016
Overall Status:	Completed
Study Start:	February 2013
Primary Completion:	December 2015 [Actual]
Study Completion:

First Submitted:	May 6, 2010
First Submitted that Met QC Criteria:	May 6, 2010
First Posted:	May 7, 2010 [Estimate]

Last Update Submitted that Met QC Criteria:	July 7, 2016
Last Update Posted:	July 11, 2016 [Estimate]


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description


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.

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.

Conditions


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

Study Design


Study Type:	Observational
Observational Study Model:	Case-Only
Time Perspective:	Prospective
Biospecimen Retention:	Samples With DNA
Biospecimen Description:	DNA
Enrollment:	350 [Anticipated]
Number of Groups/Cohorts	0

Groups and Interventions


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

Outcome Measures


Primary Outcome Measures:
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

Eligibility


Study Population:	Patients With High-Risk Acute Lymphoblastic Leukemia
Sampling Method:	Non-Probability Sample
Minimum Age:	1 Year
Maximum Age:	30 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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:

Tags

Categories

Videos


Citations:
Links:
Available IPD/Information: