Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Centre Henri Becquerel
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Analysis of circulating tumor DNA kinetics
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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…)
Arms & Interventions
Kinetics of circulating tumor DNA
Intervention: Measure of the circulating tumor DNA (Other)
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)