Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C

• Conditions: Monoclonal B-Cell Lymphocytosis; Chronic Viral Hepatitis C
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06564051
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Individuals with chronic hepatitis C who are to begin therapy with DAA

  • Willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline

Exclusion Criteria

• Individuals with chronic hepatitis C who have cirrhosis

  • Individuals with chronic hepatitis C who have a past history of a lymphoproliferative disorder AND for which they received chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection and have medical records reviewed throughout study.

Primary Outcome Measures

Name	Time	Method
Prevalence of monoclonal B-cell lymphocytosis (MBL)	Baseline; up to one year	Blood samples collected in conjunction with routine clinical blood draws will be tested for MBL and compared with post-therapy samples and with control patients (without hepatitis C).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States