Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma

A Pilot Study of Nanochip Technology for Monitoring Treatment Response and Detection of Relapse in Patients With Diffuse Large B-Cell Lymphoma

This trial studies how well nanochip technology (immuno-tethered lipoplex nanoparticle [ILN] biochip) works in monitoring treatment response and in detecting relapse in participants with diffuse large B-cell lymphoma. Finding genetic markers for diffuse large B-cell lymphoma may help identify participants with this disease and help predict the outcome of treatment. It is not yet known how well ILN biochip-based testing monitors treatment response or detects relapse in participants with diffuse large B-cell lymphoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B-Cell Lymphoma; High Grade B-Cell Lymphoma; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
• Intervention / Treatment: Procedure: Molecular Nanotechnology

Detailed Description

PRIMARY OBJECTIVES:

I. Determine whether ILN biochip can be used to detect molecular marker(s) to monitor treatment response in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

II. Determine whether ILN biochip can promote early detection of disease relapse in patients with DLBCL.

OUTLINE:

Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed treatment naive DLBCL. Subtypes including high grade B-cell lymphoma, not otherwise specified (NOS) and de-novo DLBCL including germinal center B-cell type (GCB) and non-GCB subtypes.
• Intent to receive entire care (treatment and follow-up) at Ohio State University (OSU).
• Receiving treatment with curative intent.
• Receiving planned 6 cycles of chemotherapy.
• Ability to consent.

Exclusion Criteria:

• Transformed lymphomas.
• DLBCL with leukemic presentation.
• Primary central nervous system (CNS) lymphoma.
• Participating in other clinical trial/ receiving experimental therapy.
• Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation.
• Pregnancy (positive serum or urine pregnancy test) or breast feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (ILN biochip testing); Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.	Procedure: Molecular Nanotechnology; Undergo ILN biochip testing; Other Names: MNT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response	The association of the expression measured by immuno-tethered lipoplex nanoparticle (ILN) biochip and quantitative reverse transcription polymerase chain reaction (qRT-PCR) will be displayed by scatter plot. Receiver operating characteristic (ROC) curves and corresponding area under the curves (AUCs) will be calculated and compared. With these data collected serially over time, patterns will be explored graphically using trace plots showing the trend across treatment for each individual participant.	Up to 2 years
Early detection of relapse	Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.	Up to 2 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Beth Christian, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): November 20, 2024
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: OSU-18154; NCI-2018-01536 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No