Biomarkers in DNA Samples From Patients With High-Risk Ac... | NCT01119586

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

NCT01119586

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

350Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

DNA analysis
genetic linkage analysis
microarray analysis
nucleic acid sequencing
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
COG-AALL10B2	Other Identifier	Children's Oncology Group
CDR0000672526	Other Identifier	Clinicaltrials.gov
NCI-2011-02232	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Not provided

First Submitted Date

May 6, 2010

First Submission Date that Met QC Criteria

May 6, 2010

First Posted Date

May 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2016

Last Update Posted Date

Jul 11, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Patients With High-Risk Acute Lymphoblastic Leukemia

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Todd E. Druley, MD	St. Louis Children's Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008040	Genetic Linkage
D046228	Microarray Analysis
D001483	Base Sequence
D016133	Polymerase Chain Reaction
D054458	Amplified Fragment Length Polymorphism Analysis

Ancestor Terms

ID	Term
D055614	Genetic Phenomena
D046208	Microchip Analytical Procedures
D008919	Investigative Techniques
D015394	Molecular Structure

Browse Leaves

Not provided

Browse Branches

Not provided