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

NCT06564051 | Terminated

• 2 other identifiers: 17-003975NCI-2024-01768
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Viral Hepatitis C; Monoclonal B-Cell Lymphocytosis

Outcome Measures

Primary Outcomes (1)

• Prevalence of monoclonal B-cell lymphocytosis (MBL)

  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).

  Baseline; up to one year

Study Arms (1)

Observational

Patients undergo blood sample collection and have medical records reviewed throughout study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatitis C who are to begin therapy with DAA seen in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples retained only with participant permission

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameer A. Parikh, M.B.B.S.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: November 14, 2017
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

US (1)