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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03656835
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
51.2
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Molecular Nanotechnology
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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).

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study of Nanochip Technology for Monitoring Treatment Response and Detection of Relapse in Patients With Diffuse Large B-Cell Lymphoma
Actual Study Start Date :
Sep 26, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment response [Up to 2 years]

      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.

    2. Early detection of relapse [Up to 2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Narendranath Epperla, MD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Narendranath Epperla, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03656835
    Other Study ID Numbers:
    • OSU-18154
    • NCI-2018-01536
    First Posted:
    Sep 4, 2018
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Jun 7, 2022