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

NCT ID: NCT03656835

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Molecular Nanotechnology

Intervention Type PROCEDURE

Undergo ILN biochip testing

Interventions

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Molecular Nanotechnology

Undergo ILN biochip testing

Intervention Type PROCEDURE

Other Intervention Names

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MNT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Beth Christian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth Christian, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2018-01536

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-18154

Identifier Type: -

Identifier Source: org_study_id