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

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03656835
• Other study ID #: OSU-18154
• Secondary ID: NCI-2018-01536
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Procedure:
• Molecular Nanotechnology
Undergo ILN biochip testing

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Early detection of relapse	Changes in expression between baseline and relapse will be summarized with descriptive statistics and explored graphically.	Up to 2 years

External Links

•   The Jamesline