Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT01024127
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2009-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
Genetic Predictors of AML Treatment Response
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 research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.
Detailed Description:
PRIMARY OBJECTIVES:
l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.
II. Validate positive associations seen in the genome-wide scan with a fine mapping approach.
III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.
OUTLINE:
Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.
l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.
II. Validate positive associations seen in the genome-wide scan with a fine mapping approach.
III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.
OUTLINE:
Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.
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?: