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Trial Title:
Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy
NCT ID:
NCT06141772
Condition:
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Diffuse Large B Celle Lymphoma
Circulating tumor DNA
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Measure of the circulating tumor DNA
Description:
Blood assessment to measure the kinetics au circulating tumor DNA
Arm group label:
Kinetics of circulating tumor DNA
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.
Criteria for 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...)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Zip:
76000
Country:
France
Contact:
Last name:
Fabrice Jardin
Phone:
+33232082465
Email:
fabrice.jardin@chb.unicancer.fr
Start date:
November 15, 2023
Completion date:
May 15, 2025
Lead sponsor:
Agency:
Centre Henri Becquerel
Agency class:
Other
Source:
Centre Henri Becquerel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06141772
