Non Hodgkin LymphomaLymphoSeqNCT02339805
Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS
A study testing next generation sequencing and Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in people with Non Hodgkin Lymphoma, run by Centre Henri Becquerel at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- next generation sequencing and Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the 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.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- next generation sequencing, Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)
- Keywords
- Minimal residual disease, NGS, NHL, DNA sequencing
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next generation sequencingOther
DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.
Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)Device
tumor Assessment tool during the study
| Study group | Role | What they receive |
|---|---|---|
| next generation sequencing | Experimental | Determination of clonotypic evolution of the minimal residual disease by next generation sequencing. Receives: Other: next generation sequencing; Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (4)
Progression free survival
time between inclusion and progression or relapse or beginning of a new treatment
Measured: One year
Overall survival
time between inclusion and death
Measured: one year
Assess the clonal architecture in tumor DNA and bone marrow
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study start1 Nov 2014
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Collaborators
- U918 ( Inserm unit)
- Responsible party
- Sponsor
- Investigators
- Fabrice Jardin, Professor, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339805
- Sponsor's protocol ID
- CHB13.03
- Acronym
- LymphoSeq
- Status last verified
- Jul 2017
- First submitted
- 13 Jan 2015
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26883583
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02339805
- Acronym / sponsor ID
- LymphoSeq / CHB13.03
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- Minimal residual disease, NGS, NHL, DNA sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Collaborators
- U918 ( Inserm unit)
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| next generation sequencing | Experimental | Other: next generation sequencing, Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)Determination of clonotypic evolution of the minimal residual disease by next generation sequencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| next generation sequencingDNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes. | Other | next generation sequencing |
| Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)tumor Assessment tool during the study | Device | next generation sequencing |
Primary outcome
Determine the clonal evolution during and after treatment by Next Generation Sequencing
Time frame: one year
DNA from tumor, DNA from peripheral blood and DNA from bone marrow will be sequencing by NGS for a panel of 34 genes.
4 secondary outcomes
Progression free survival
Time frame: One year
Overall survival
Time frame: one year
Assess the clonal architecture in tumor DNA and bone marrow
Time frame: 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
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Derived from this study: PubMed 26883583Camus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Jardin, Professor principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing next generation sequencing and Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in people with Non Hodgkin Lymphoma, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the clonal evolution during and after treatment by Next Generation Sequencing (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.