NCT02339805

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

January 13, 2015

Last Update Submit

July 5, 2017

Conditions

Non Hodgkin Lymphoma

Keywords

Minimal residual disease, NGS, NHL, DNA sequencing

Outcome Measures

Primary Outcomes (1)

  • Determine the clonal evolution during and after treatment by Next Generation Sequencing

    DNA from tumor, DNA from peripheral blood and DNA from bone marrow will be sequencing by NGS for a panel of 34 genes.

    one year

Secondary Outcomes (4)

  • Progression free survival

    One year

  • Overall survival

    one year

  • Assess the clonal architecture in tumor DNA and bone marrow

    one year

  • Compare the Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) procedure and the kinetic and pattern of somatic mutations identified in cfDNA

    one year

Study Arms (1)

next generation sequencing

EXPERIMENTAL

Determination of clonotypic evolution of the minimal residual disease by next generation sequencing.

Other: next generation sequencingDevice: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

Interventions

next generation sequencingOTHER

DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.

next generation sequencing
Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)DEVICE

tumor Assessment tool during the study

next generation sequencing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

Related Publications (1)

  • 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.

    PMID: 26883583DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinNeoplasm, Residual

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • Fabrice Jardin, Professor

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 15, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

FR(1)