Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas

Not Applicable

Recruiting

• Conditions: Lymphoma
• Interventions: Diagnostic Test: cell-free DNA

• Registration Number: NCT05676450
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

Detailed Description

Primary Objective:

• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.

Secondary Objectives:

* To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations

* Levels of cfDNA and its association with both EFS and OS in patients receiving therapy

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-02-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.
2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
3. Provision of written informed consent for the study.
4. Pregnant women not included
5. Cognitively impaired adults are not included.

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cell-free DNA (cfDNA) samples	cell-free DNA	cell-free DNA (cfDNA) samples from DLBCL participants before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method. Blood will be drawn 3 times (by vein)

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion; an average 1 year

Trial Locations

Locations (2)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States