NCT06141772

Brief Summary

The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

October 17, 2023

Last Update Submit

December 29, 2025

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B Celle LymphomaCirculating tumor DNA

Outcome Measures

Primary Outcomes (1)

  • Analysis of circulating tumor DNA kinetics

    Blood assessment to measure circulating tumor concentration

    21 days

Secondary Outcomes (1)

  • Correlation between circulating tumor DNA concentration and metabolic volume

    6 months

Study Arms (1)

Kinetics of circulating tumor DNA

EXPERIMENTAL
Other: Measure of the circulating tumor DNA

Interventions

Measure of the circulating tumor DNAOTHER

Blood assessment to measure the kinetics au circulating tumor DNA

Kinetics of circulating tumor DNA

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Diffuse Large B Cell Lymphoma
  • TEP-TDM at diagnosis
  • Inform Consent form signed
  • Performance status 0 or 1
  • Hospitalized on clinician decision for first cycle of R-CHOP or R-miniCHOP

You may not qualify if:

  • Histology other than Diffuse Large B Cell
  • Patient under guardianship or curatorship
  • Incapacity to understand the study or conform to the constraints of the study (language barrier, psychological barrier, geographic barrier…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Fabrice Jardin, MD,PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2023

First Posted

November 21, 2023

Study Start

December 21, 2023

Primary Completion

November 4, 2024

Study Completion

April 10, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

FR(1)