Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564051
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Observational Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C
Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C
Detailed Description:
PRIMARY OBJECTIVES
I To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral DAA and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic
II To determine the correlation between the specific subtype of MBL CD5- MBL atypical CLL-phenotype MBL and CLL-phenotype MBL relative to the hepatitis C virus HCV genotype
III To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA
OUTLINE This is an observational study
Patients undergo blood sample collection and have medical records reviewed throughout study
I To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral DAA and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic
II To determine the correlation between the specific subtype of MBL CD5- MBL atypical CLL-phenotype MBL and CLL-phenotype MBL relative to the hepatitis C virus HCV genotype
III To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA
OUTLINE This is an observational study
Patients undergo blood sample collection and have medical records reviewed throughout study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: