Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02861651
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2016-07-08
Brief Title:
Molecular Characterization of Acute Erythroid Leukemia M6-AML Using Targeted Next-generation Sequencing
Sponsor:
Institut Paoli-Calmettes
Organization:
Institut Paoli-Calmettes
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Acute erythroid leukemia AEL is a morphologically distinct infrequent o5 acute myeloid leukemia AML designed as M6 in the French- American-British FAB classification The World Health Organization classification recognizes two subclasses M6a a leukemia with myeloid blast cells and M6b a very rare purely erythroid AML It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation which is increased when dysplasia is present No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations respectively Only three cases of AEL are reported in the TCGA database To further characterize AEL determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization aCGH and next-generation sequencing NGS of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation
Detailed Description:
None
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