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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molecular Nanotechnology
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diffuse Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (ILN biochip testing)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Early detection of relapse
Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2018
Last Updated
June 2, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03656835
Brief Title
Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma
Official Title
A Pilot Study of Nanochip Technology for Monitoring Treatment Response and Detection of Relapse in Patients With Diffuse Large B-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (ILN biochip testing)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Molecular Nanotechnology
Other Intervention Name(s)
MNT
Intervention Description
Undergo ILN biochip testing
Primary Outcome Measure Information:
Title
Treatment response
Description
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.
Time Frame
Up to 2 years
Title
Early detection of relapse
Description
Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lily Yang
Phone
614-293-6191
Email
lily.yang@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narendranath Epperla, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lily Yang
Phone
614-293-6191
Email
lily.yang@osumc.edu
First Name & Middle Initial & Last Name & Degree
Narendranath Epperla, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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