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Clinical Trials/NCT06141772
NCT06141772
Completed
Not Applicable

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

Centre Henri Becquerel1 site in 1 country24 target enrollmentDecember 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diffuse Large B Cell Lymphoma
Sponsor
Centre Henri Becquerel
Enrollment
24
Locations
1
Primary Endpoint
Analysis of circulating tumor DNA kinetics
Status
Completed
Last Updated
4 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2023
End Date
April 10, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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…)

Outcomes

Primary Outcomes

Analysis of circulating tumor DNA kinetics

Time Frame: 21 days

Blood assessment to measure circulating tumor concentration

Secondary Outcomes

  • Correlation between circulating tumor DNA concentration and metabolic volume(6 months)

Study Sites (1)

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