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

NCT03656835 | Active Not Recruiting DMC

• 2 other identifiers: OSU-18154NCI-2018-01536
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Diffuse Large B-Cell Lymphoma; High Grade B-Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Diagnostic (ILN biochip testing)

EXPERIMENTAL

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

Interventions

Molecular Nanotechnology PROCEDURE

Undergo ILN biochip testing

Also known as: MNT

Diagnostic (ILN biochip testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Beth Christian, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 4, 2018
• Study Start: September 26, 2018
• Primary Completion: November 20, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)