Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489613
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-28
Brief Title:
Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology
Sponsor:
Jian Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
iMS-LC Assay intact M-protein Screening-Light Chain Assay is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood
The investigators propose to conduct a prospective single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology The goals of this observational study are 1 to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method and 2 to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening
Initially the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay using the clinical methods SPEP SIFE FLC as the gold standard Based on the diagnostic performance of the iMS-LC Assay the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations to further determine the prevalence of MGUS in this population based on mass spectrometry screening
The investigators propose to conduct a prospective single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology The goals of this observational study are 1 to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method and 2 to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening
Initially the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay using the clinical methods SPEP SIFE FLC as the gold standard Based on the diagnostic performance of the iMS-LC Assay the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations to further determine the prevalence of MGUS in this population based on mass spectrometry screening
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None