Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 5:15 AM
Study NCT ID:
NCT01076569
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.
III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
IV. To identify genomic alterations contributing to induction failure in childhood AML.
OUTLINE:
Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.
I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.
III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
IV. To identify genomic alterations contributing to induction failure in childhood AML.
OUTLINE:
Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: