NCT05676450

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for not_applicable lymphoma

Timeline
4mo left

Started Feb 2023

Typical duration for not_applicable lymphoma

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Aug 2026

First Submitted

Initial submission to the registry

December 15, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

3.5 years

First QC Date

December 15, 2022

Last Update Submit

October 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    through study completion; an average 1 year

Study Arms (1)

cell-free DNA (cfDNA) samples

OTHER

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)

Diagnostic Test: cell-free DNA

Interventions

cell-free DNADIAGNOSTIC_TEST

Given by IV (vein)

cell-free DNA (cfDNA) samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

Noninvasive Prenatal Testing

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Liquid BiopsyBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic TestingSpecimen HandlingPrenatal DiagnosisDiagnostic Techniques, Obstetrical and GynecologicalInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Chijioke Nze, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chijioke Nze, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 9, 2023

Study Start

February 23, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

October 31, 2025

Record last verified: 2025-10

Locations