Clinical trial NCT02339805: Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS
Official title: Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Hodgkin Lymphoma
Keywords: Minimal residual disease, NGS, NHL, DNA sequencing
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
Collaborators: name: U918 ( Inserm unit)
First posted: 2015-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment

Detailed description: To determinate and to describe the clonal evolution, 30 DLBCL cases with available matched tumor DNA and plasma will be collected and analyzed by routinely applicable next generation sequencing (NGS) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.

Eligibility criteria: Inclusion Criteria:

* Age up to 18 years old
* With a diagnosis formally established of DLBCL or transformed straightaway follicular lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma
* Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like
* First line of treatment
* Being able to benefit from standard extension assessment ( Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy with a bone marrow aspiration)
* Written informed consent
* Tumor biopsy used for diagnosis available

Exclusion Criteria:

* Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like
* Patient who cannot benefit from standard extension assessment and follow-up by with Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)
* Pregnant or breast-feeding woman
* Guardianship, curatorship
* Patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons

Primary outcomes:
measure: Determine the clonal evolution during and after treatment by Next Generation Sequencing
timeFrame: one year
Secondary outcomes:
measure: Progression free survival
timeFrame: One year
measure: Overall survival
timeFrame: one year
measure: Assess the clonal architecture in tumor DNA and bone marrow
timeFrame: one year
measure: Compare the Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) procedure and the kinetic and pattern of somatic mutations identified in cfDNA
timeFrame: one year
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Fabrice Jardin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camus V, Sarafan-Vasseur N, Bohers E, Dubois S, Mareschal S, Bertrand P, Viailly PJ, Ruminy P, Maingonnat C, Lemasle E, Stamatoullas A, Picquenot JM, Cornic M, Beaussire L, Bastard C, Frebourg T, Tilly H, Jardin F. Digital PCR for quantification of recurrent and potentially actionable somatic mutations in circulating free DNA from patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2016 Sep;57(9):2171-9. doi: 10.3109/10428194.2016.1139703. Epub 2016 Feb 17.