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Completed

NCT Number: NCT06141772

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

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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Measure of the circulating tumor DNA

Other

Blood assessment to measure the kinetics au circulating tumor DNA

Primary outcomes

  1. Analysis of circulating tumor DNA kinetics

    Time frame: 21 days

    Blood assessment to measure circulating tumor concentration

Secondary outcomes

  1. Correlation between circulating tumor DNA concentration and metabolic volume

    Time frame: 6 months

    comparison between circulating tumoral concentration and metabolic volume measured on TEP

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma

Acronym: LYMPHO-CLEAR

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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