Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy

NCT ID: NCT06141772

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2025-04-10

Brief Summary

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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.

Detailed Description

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ctDNA in diffuse large B cell lymphoma (DLBCL) has become an essential dynamic biomarker. Due to its short half-life, ctDNA is a real-time reflection of tumoral evolution and is a non-invasive biomarker that can be used for patient evaluation and follow-up. The quantity of ctDNA before treatment is correlated with tumoral mass, international prognostic index (IPI) and prognosis. The principal mechanism of ctDNA release is tumor cell apoptosis and it is well established that tumor cell apoptosis is observed in the hours following immuno-chemotherapy. However, the kinetics of ctDNA concentration in the hours following immuno-chemotherapy administration is unknown.

Modelizing the kinetics of ctDNA during this early timeframe could help to better predict chemo-sensitivity and better reflect genetic heterogeneity of the tumor, through release of a larger quantity of ctDNA compared to baseline.

Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Kinetics of circulating tumor DNA

Group Type EXPERIMENTAL

Measure of the circulating tumor DNA

Intervention Type OTHER

Blood assessment to measure the kinetics au circulating tumor DNA

Interventions

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Measure of the circulating tumor DNA

Blood assessment to measure the kinetics au circulating tumor DNA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 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

Exclusion Criteria

* 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…)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice Jardin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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CHB23.05

Identifier Type: -

Identifier Source: org_study_id

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