Ignite Creation Date:
2024-05-05 @ 9:27 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00897936
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2009-05-09
Brief Title:
DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs NPM Negative NCL
Status:
COMPLETED
Status Verified Date:
2020-07
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:
RATIONALE Studying samples of 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 It may also help doctors predict how well patients respond to treatment
PURPOSE This laboratory study is looking at tissue samples from patients with acute myeloid leukemia
PURPOSE This laboratory study is looking at tissue samples from patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine gene expression genome integrity cytosine methylation and chromatin structure in patients with normal cytogenetics leukemia NCL acute myeloid leukemia
Determine whether NCL can be deconstructed into specific disease entities by analysis of the integrated genomic and epigenomic datasets using supervised and unsupervised methods in these patients
Identify the gene pathways that define NCL subtypes and molecular targets for validation in preclinical and clinical trials for these patients
Determine whether integrated analysis provides markers of prognostic and therapeutic response that accurately predicts clinical outcome and can be used to select patients for risk-stratified therapeutic trials
OUTLINE This is a pilot multicenter study
Samples are analyzed to assess array comparative genomic hybridization using polymerase chain reaction PCR and fluorescent in situ hybridization chromatin immunoprecipitations chip using PCR Hpa II tiny fragment enrichment by ligation-mediated PCR HELP using DNA methylation analysis and gene expression profiling
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study
Primary
Determine gene expression genome integrity cytosine methylation and chromatin structure in patients with normal cytogenetics leukemia NCL acute myeloid leukemia
Determine whether NCL can be deconstructed into specific disease entities by analysis of the integrated genomic and epigenomic datasets using supervised and unsupervised methods in these patients
Identify the gene pathways that define NCL subtypes and molecular targets for validation in preclinical and clinical trials for these patients
Determine whether integrated analysis provides markers of prognostic and therapeutic response that accurately predicts clinical outcome and can be used to select patients for risk-stratified therapeutic trials
OUTLINE This is a pilot multicenter study
Samples are analyzed to assess array comparative genomic hybridization using polymerase chain reaction PCR and fluorescent in situ hybridization chromatin immunoprecipitations chip using PCR Hpa II tiny fragment enrichment by ligation-mediated PCR HELP using DNA methylation analysis and gene expression profiling
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1900T2 | None | None | None |