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

Study Overview
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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.

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

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

Intervention / Treatment
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* Procedure: Molecular Nanotechnology


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (ILN biochip testing)<br>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<br>* Undergo ILN biochip testing<br>* Other names: MNT;|

What is the study measuring?
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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 |