Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552221
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Finistere Myeloma Observatory OMYFIN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Finistere Myeloma Observatory Retrospective Study of Chromosome 1 Abnormalities and Prognostic Value of a CKS1B on 1q21CDKN2C on 1p32 Copy Number Ratio in Myeloma
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMYFIN
Brief Summary:
Current molecular risk stratification of multiple myeloma MM based on the presence of t4 14 and 17p deletion cannot fully explain treatment outcome heterogeneity as other features also predict prognosis About 30 of genetic events map to chromosome 1 most upregulated genes to 1q and most downregulated ones to 1p CKS1B gains on 1q21 and CDKN2C loss on 1p32 both favoring cell cycle progression portended impaired outcome in many but not all studies Based on their recurrence and considering their functional convergence we hypothesized CKS1BCDKN2C copy number ratio to be a risk factor fitter than each aberration alone
Detailed Description:
This single-center retrospective study is designed to enroll all consecutive newly diagnosed adult patients aged 18 years transplant-eligible and not All patients are routinely tested for CKS1B and CDKN2C and treated according to consensus guidelines Data are being collected from 2012 For each subject we calculate a FISH-based ratio by CKS1B on CDKN2C copy number it is equal to 1 with no change in copy number and 1 in case of CKS1B gains CDKN2C loss or both In patients with CDKN2C biallelic loss the ratio is not equal to 0 but to CKS1B copy number as functional consequence should prevail over arithmetic result We will then analyze separately the impact of CKS1B gains CDKN2C loss and CKS1BCDKN2C ratio on PFS and OS
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