Study to Assess Monoclonal B-Cell Lymphocytosis in Indivi... | NCT06564051

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

NCT06564051

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Jan 6, 2026Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Chronic Viral Hepatitis C
Monoclonal B-Cell Lymphocytosis

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2024-01768	Registry Identifier	CTRP (Clinical Trial Reporting Program)
17-003975	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow accrual

Expanded Access Info

Start Date

Nov 14, 2017Actual

Primary Completion Date

Dec 3, 2025Actual

Completion Date

Dec 3, 2025Actual

First Submitted Date

Aug 19, 2024

First Submission Date that Met QC Criteria

Aug 19, 2024

First Posted Date

Aug 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2025

Last Update Posted Date

Jan 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients undergo blood sample collection and have medical records reviewed throughout study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameer A. Parikh, M.B.B.S.	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided